Clinical Validation

Industry insight: the biotech sector battles with COVID-19 | 9/10/2020

… settings. Through the collaboration with the CONDOR scheme, Avacta will be provided access to patient samples and collaborators in UK hospitals to evaluate the performance of the prototype BAMS assay and to conduct the clinical validation study. The partnership with LSTM provides the opportunity to access patient samples in Africa and South America, where the higher prevalence of the disease means that samples for prospective clinical validation studies are more …

DermTech Announces Appointment of Chief Scientific Officer - GuruFocus.com | 9/8/2020

… of Michael D. Howell, Ph.D., to the role of Chief Scientific Officer. Mr. Howell brings over twenty years of academic and pharmaceutical industry experience to DermTech and will coordinate research, new product development, and clinical validation efforts. “I am extraordinarily pleased that Michael Howell is joining our team,” said John Dobak, M.D., CEO of DermTech. “Mr. Howell has been a DermTech scientific advisor for several years and his depth of …

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With partnerships at major children’s hospitals, Manatee seeks clinical validation of its CBT-based app | 7/7/2020

Menu and widgets With partnerships at major children’s hospitals, Manatee seeks clinical validation of its CBT-based app When Manatee founder Damayanti Dipayana’s brother was diagnosed with autism spectrum disorder, the family took all the steps to ensure that he was properly cared for. All of the things that could have been an obstacle to getting treatment weren’t for Dipayana’s family. A comfortably middle class background, a supportive family and …

With partnerships at major children’s hospitals, Manatee seeks clinical validation of its CBT-based app – TechCrunch | 7/7/2020

… Grand Ventures ; Telosity , a fund launched by Vinaj Ventures & Innovation, that invests in companies improving children’s and young adult’s mental health; and the American Family Insurance Institute for Corporate and Social Impact, will pursue clinical validation for its suite of apps and services to provide a continuum of care for children with cognitive and behavioral disorders. Beginning with Children’s Hospital Los Angeles , Manatee has started a trial with ten clinicians …

Current status of development of methylation biomarkers for in vitro diagnostic IVD applications | 7/6/2020

… target population which is a patient group subjected to testing (Fig. 1 a). Clear definition of the intended use of and target population are critical for the recruitment of the specific patient group for clinical validation studies which in principle, are well-controlled and systematic investigations aiming to show clear benefit and safety of use of the biomarker in clinical practice (Fig. 1 d). Overall, clinical validation studies need to …

Renalytix AI says positive study results published in key US journal | 1 July 2020 | Stock Market Wire | 7/1/2020

Diagnostics group for kidney disease Renalytix AI said positive results of a clinical validation study had undergone peer-review and been accepted for publication in the American Society of Nephrology Journal, Kidney360. The study provided details of the primary analysis and numerous sub-analyses, which demonstrate robust performance of the company’s KidneyIntelX test in the two clinical contexts, it said. At 9:07am: [ LON:RENX ] Renalytix Ai PLC share price was …

RenalytixAI Announces KidneyIntelX Validation Study Accepted for Publication in American Society of Nephrology Journal Kidney360 | BioSpace | 7/1/2020

NEW YORK , July 1, 2020 /PRNewswire/ – Renalytix AI plc (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and lower healthcare costs, today announced that results of a clinical validation study have undergone peer-review and have been accepted for publication in the American Society of Nephrology Journal, Kidney360 . The published manuscript titled, “Validation of a …

Episode 86: Sponsored | Panoramic Microbial Assessment: The GI360™ Stool Test with David Quig, PhD | 7/1/2020

… between the microbiomes in people with IBS and IBD against normal biosis. And so based on the literature, they then proceeded and came up with a final combination of 45 different probes and in clinical validation , in applying these probes, found that it was very powerful at discerning between dysbiosis and normal biosis. Dysbiosis being in IBS, as per Rome III criteria, and IBD by scoping and biopsy. So not …

Facebook cofounder Saverin’s B Capital just closed its third flagship fund with $822 million | TechCrunch | 6/30/2020

… Bay Area, especially when it comes to companies whose cross-border strategies it can help develop. For example, B Capital has backed Evidation Health, an eight-year-old, San Mateo, Calif. company that provides clinical validation of health apps and that is expanding into Asia with the help of B Capital. B Capital, which has two partners in San Francisco, also sees a growing number of interesting startups with a …

Immunovant Reports Financial Results for the Quarter and Fiscal Year Ended March 31, 2020 and Announces Plans for Phase 3 Registrational Trial of IMVT-1401 in Myasthenia Gravis | Globe Newswire | 6/29/2020

… s prior safety and pharmacodynamic findings and demonstrated encouraging potential efficacy for patients with TED. Complementing these findings, two recent successful studies for other drug candidates with the same mechanism of action provided strong clinical validation in MG and demonstrated a within-study relationship between the degree of IgG lowering and the magnitude of clinical benefit in MG. With proof-of-biology now established for anti-FcRn agents in MG …

Direct Supply Partners with SafelyYou to Reduce Falls in Senior Living Amid COVID-19 and Beyond | PR Newswire | 6/29/2020

… an ITC strategic partner and a solution accelerator, focusing almost exclusively on solutions for those affected by cognitive decline. “We are working with SafelyYou through our Industry Innovation Partnership Program (I2P2) to conduct a clinical validation study to test its fall-detection technology in a real-world environment,” said Mel Barsky , Director of Business Development for CABHI. “We are eagerly awaiting the results based on the success of previous studies …

Immunovia to Present a Satellite Symposium at the European Pancreatic Club (EPC) - International Association of Pancreatology’s (IAP) Annual Meeting July 2, 2020 | PR Newswire | 6/29/2020

… is open and can be made via this link: https://www.epc2020.eu/ Details on Immunovia’s Satellite Symposium: Date: July 2, 2020 Time: 12.20-12.40 CET Presentation Title: First-In-Class IMMray™ PanCan-d Enters Final Clinical Validation Stages for launch Q4 2020 for Early Detection of Pancreatic Cancer Presented by: MD Thomas King, Medical Director, Immunovia. The Q&A session will be hosted by PhD Laura Chirica, Chief Commercial Officer, Immunovia …

Oncocyte Announces Completion of DetermaDx™ Clinical Validation Study | Globe Newswire | 6/29/2020

Prospective, blinded clinical validation study did not achieve pre-defined endpoint of improvement over routinely used clinical factors for managing patients with radiologically identified lung nodules Company to now focus resources on accelerating DetermaRx ™ and DetermaIO ™, which are currently being commercialized for the clinical and biopharma markets, respectively Conference call today, June 29, at 5:00 p.m. EDT IRVINE, Calif., June 29, 2020 (GLOBE NEWSWIRE) – Oncocyte Corporation (NYSE American: OCX), a …

Oncocyte strikes out with liquid biopsy lung nodule test | 6/29/2020

Oncocyte (NYSEMKT: OCX ) announces unsuccessful results from a clinical validation study of DetermaDx, a liquid biopsy test aimed at determining whether a lung nodule is suspicious or benign. The study failed to achieved the main endpoint of a statistically significant improvement in the diagnosis of intermediate-risk nodules, particularly in the 0.8 cm – 22 cm size range, compared to clinical factors used by doctors. The company will cease further development …

Scientist, New Product Introduction - Cepheid - Sunnyvale, CA | 6/28/2020

SAP extension and costing �?? Develop and maintain production documentation including procedures, worksheets, and bills of materials. Use technical knowledge to troubleshoot assay design challenges encountered during the course of assay development, clinical validation or manufacturing validation. Maintain substantial and current knowledge of validation and process control requirements mandated by applicable regulatory bodies. Minimum Qualifications Education and Experience (in years): Bachelor�??s degree in field with 5+ years of related work …

2cureX receives third payment from the EU’ Horizon 2020 SME- Instrument Program | 6/25/2020

2cureX receives third payment from the EU’ Horizon 2020 SME- Instrument Program Thu, Jun 25, 2020 08:30 CET 2cureX AB (“2cureX”) today announces that the company has received a third payment of EUR 596,886 from the EU’s Horizon 2020 SME Program . The grant is given to finalize the clinical validation of the company’s IndiTreat® product and to initiate market launch. As previously communicated, 2cureX has in February 2018 started a …

New Study Demonstrates the Ability of myPath® Melanoma to Accurately Classify Lesions Ruled Indeterminate by Standard Pathological Assessment | BioSpace | 6/25/2020

… demonstrated 90.4 percent sensitivity and 95.5 percent specificity in the indeterminate sample cohort and 93.8 percent sensitivity and 96.2 percent specificity when evaluating the entire sample cohort. This data is consistent with multiple other clinical validation studies for myPath Melanoma which have demonstrated the ability of the test to delineate melanoma from benign skin lesions with high diagnostic accuracy. About Melanoma According to the American Cancer Society , approximately 100,350 Americans …

New Study Demonstrates the Ability of myPath® Melanoma to Accurately Classify Lesions Ruled … | 6/25/2020

… demonstrated 90.4 percent sensitivity and 95.5 percent specificity in the indeterminate sample cohort and 93.8 percent sensitivity and 96.2 percent specificity when evaluating the entire sample cohort. This data is consistent with multiple other clinical validation studies for myPath Melanoma which have demonstrated the ability of the test to delineate melanoma from benign skin lesions with high diagnostic accuracy. About Melanoma According to the American Cancer Society , approximately 100,350 Americans …

Partnership for the Clinical Validation of Textile Computing Solutions | 6/24/2020

Partnership for the Clinical Validation of Textile Computing Solutions Myant Inc, pioneers in textile computing, and KITE Research Institute, the research arm of Toronto Rehabilitation Institute (a member of the University of Health Network), have announced a multiyear co-development partnership that leverages the Myant Platform, the company’s core textile computing technology (commercially known as Skiin), as well as research from KITE and UHN to develop and clinically validate an …

Avacta Provides Update on COVID-19 Rapid Antigen Test Development Partnership With Cytiva | Business Wire | 6/24/2020

… Cytiva the design will then be transferred to manufacturing partners in the UK that are currently being put in place by Avacta. The Company is working with these manufacturers to compress the normal manufacturing, clinical validation and regulatory timelines in order to bring a product to market as quickly as possible. Dr. Alastair Smith, Chief Executive of Avacta Group commented: “I am delighted with the progress made by our partners …

VUNO Obtains CE Mark for 5 of Their Medical AI Solutions | PR Newswire | 6/24/2020

… those in the Middle East , Asia , South and Central America , and Africa . VUNO was assessed and deemed to meet EU safety and health protection requirements by a Notified Body based on a more stringent clinical validation standards and medical device guidelines. The efficacy and safety of those products demonstrated by a series of clinical research results and papers published in high impact journals and prestigious international seminars were of great …

Sera Prognostics Appoints Thomas J. Garite, M.D. as Vice President of Clinical Sciences | Business Wire | 6/24/2020

… its advanced mass spectrometry platform, Sera detects biologically important protein expression changes to build high performing predictions of risk for adverse pregnancy outcomes (including preterm birth, preeclampsia, gestational diabetes, growth restriction, and others). Rigorous clinical validation of PreTRM® test performance (accuracy of predicting premature delivery) was reported in the American Journal of Obstetrics & Gynecology in 2016 in a US cohort of 5,501 patients across 11 centers. Subsequent scientific work has …

Sera Prognostics Appoints Thomas J. Garite, M.D. as Vice President of Clinical Sciences - Business Wire | 6/24/2020

… its advanced mass spectrometry platform, Sera detects biologically important protein expression changes to build high performing predictions of risk for adverse pregnancy outcomes (including preterm birth, preeclampsia, gestational diabetes, growth restriction, and others). Rigorous clinical validation of PreTRM® test performance (accuracy of predicting premature delivery) was reported in the American Journal of Obstetrics & Gynecology in 2016 in a US cohort of 5,501 patients across 11 centers. Subsequent scientific work has …

STORM Therapeutics Appoints Dr. Josefin-Beate Holz as Chief Medical Officer | PR Newswire | 6/23/2020

… held executive managerial positions at international pharmaceutical & biotech companies Ablynx, GPC-Biotech, Gilead Sciences, Bristol-Myers Squibb and LEO Pharma. Dr. Holz has worked on more than 50 disease targets at various stages of clinical validation across oncology, immunology and other indications. Commenting on today’s appointment, Dr Keith Blundy , CEO of STORM Therapeutics said: “We are pleased to welcome Josefin to STORM. This is an exciting time as we accelerate …

Insurance Companies Benefit From Reduced Healthcare Reimbursements, Lowering Costs by Approving the Sustained Acoustic Medicine (sam®) Device | PR Newswire | 6/23/2020

… comes with a one-year warranty. sam ® 2.0 is new technology approved in 2020 by the FDA for use at home. The device is completely unique and based on seven years of development and clinical validation . The generation-one device costs $4,400 and the generation-two device costs $6,800 . These prices are modestly expensive considering the significant improvements they give patients. Since the generation-two version of sam ® is for …

COVID-19

Immunovant Reports Financial Results for the Quarter and Fiscal Year Ended March 31, 2020 and Announces Plans for Phase 3 Registrational Trial of IMVT-1401 in Myasthenia Gravis | Globe Newswire | 6/29/2020

… TED. Complementing these findings, two recent successful studies for other drug candidates with the same mechanism of action provided strong clinical validation in MG and demonstrated a within-study relationship between the degree of IgG … said Dr. Salzmann. In light of the challenges created by COVID-19, including some clinical sites closing enrollment for new patients, Immunovant has taken several actions to ensure patient safety and quality trial execution. “During …

Clinical Research

Sera Prognostics Appoints Thomas J. Garite, M.D. as Vice President of Clinical Sciences - Business Wire | 6/24/2020

… Garite served as Director of Research and Education for Obstetrix, MedNax Medical Group where he directed the only ongoing Collaborative Clinical Research group composed of a consortium of private practices and university Maternal-Fetal medicine … preterm birth, preeclampsia, gestational diabetes, growth restriction, and others). Rigorous clinical validation of PreTRM® test performance (accuracy of predicting premature delivery) was reported in the American Journal of Obstetrics & Gynecology in 2016 in a US …

Biotech

STORM Therapeutics Appoints Dr. Josefin-Beate Holz as Chief Medical Officer | PR Newswire | 6/23/2020

CAMBRIDGE, England STORM Therapeutics, the leading biotechnology company focused on the discovery and development of small molecule therapies modulating RNA epigenetics, today announces the appointment of Dr. Josefin-Beate Holz as Clinical Advisor and Chief … on more than 50 disease targets at various stages of clinical validation across oncology, immunology and other indications. Commenting on today’s appointment, Dr Keith Blundy , CEO of STORM Therapeutics said: “We are pleased to welcome …

Food and Drug Administration

Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain | Business Wire | 6/22/2020

DUBLIN- Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Premarket Approval (PMA) application for ReActiv8 ® , its implantable neurostimulation system to treat … the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability in the future. ReActiv8 has also been admitted to the Australian Register of …

Department of Health and Human Services

Empatica and BARDA Join Forces to Validate Wearable System That Detects COVID-19 Before Symptoms Appear | PR Newswire | 6/19/2020

… Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to validate an early warning system for COVID … detection algorithm would not have reached this pivotal stage of clinical validation, which will accelerate our request for FDA’s approval of Aura as a medical product for use by people at risk of contracting COVID …

AACR

I-Mab and ABL Bio to Present Preclinical Data for Joint Bispecific Antibody Program at the 2020 American Association for Cancer Research Virtual Meeting II | Yahoo News | 6/12/2020

… will be presenting preclinical data on a newly developed, novel asset TJ-CD4B, at the American Association for Cancer Research (AACR) Virtual Annual Meeting II on June 22-24, 2020. I-MAB Logo (PRNewsfoto/I-Mab … enhancing anti-tumor immunity while potentially minimizing toxicity. The pre-clinical validation of TJ-CD4B/ABL111 to be presented at AACR signifies the overall progress of I-Mab’s bispecific antibody portfolio, reflecting Company’s discovery and …

American Association for Cancer Research

I-Mab and ABL Bio to Present Preclinical Data for Joint Bispecific Antibody Program at the 2020 American Association for Cancer Research Virtual Meeting II | Yahoo News | 6/12/2020

… and commercialization of novel biologics, will be presenting preclinical data on a newly developed, novel asset TJ-CD4B, at the American Association for Cancer Research (AACR) Virtual Annual Meeting II on June 22-24, 2020. I … enhancing anti-tumor immunity while potentially minimizing toxicity. The pre-clinical validation of TJ-CD4B/ABL111 to be presented at AACR signifies the overall progress of I-Mab’s bispecific antibody portfolio, reflecting Company’s discovery and …

Precision Medicine

Curesponse Secures $6M Series A for Breakthrough Precision Medicine | PR Newswire | 6/10/2020

Curesponse is a cancer precision medicine company whose platform, cResponse, accurately and quickly predicts a patient’s response to cancer treatment. - The company has raised $6M from investors including NCL Technology Ventures (UK) and aMoon ( Israel … published in Nature and Science. While the platform is undergoing clinical validation in Israeli hospitals, this investment raise will allow scaling the trials to the UK. The Global Precision Medicine Market size exceeded USD 57 …

American Society of Clinical Oncology

New ASCO Studies Offer Evidence for Use of Circulating Tumor Cells as a Prognostic Biomarker for Advanced Prostate and Breast Cancer | PR Newswire | 6/9/2020

… Italy and HUNTINGDON VALLEY, Pa. Menarini Silicon Biosystems, the pioneer of liquid biopsy and single cell technologies, announced today that results from a new study presented at the virtual 2020 meeting of the American Society of Clinical Oncology (ASCO) suggest that circulating tumor cell (CTC) counts may be useful in determining long-term prognosis and guiding treatment selection in patients with metastatic castrate sensitive prostate cancer (mCSPC). A second study …

Population Health

Integrated Behavioral Health (IBH) Announces the Nation’s First Enhanced Caregiver Service to Address Loneliness, in Alliance with Papa | PR Newswire | 6/1/2020

IRVINE, Calif. , June 1, IBH Population Health Solutions (Integrated Behavioral Health, Inc.), a leader in behavioral health nationwide, today announced it is expanding its offering through a partnership with Papa, Inc. to help employees struggling to find help or care for their older loved ones. The new caregiver plus program is an enhancement to IBH’s employee assistance programs (EAPs) to help members care for older loved ones and provide support …

Medicare

Oncocyte Provides Corporate Update And Reports First Quarter 2020 Financial Results | Globe Newswire | 5/12/2020

Announced Final Medicare LCD from Palmetto for DetermaRx™, Potentially Establishing Medicare Coverage for up to 70% of Eligible Early-Stage NSCLC Patients Signed First Strategic International Collaboration for DetermaRx with CORE, a Leading Molecular Reference Lab in India, the Middle East and Africa DetermaDx™ Clinical Validation Results On-Track for End of Q2 2020 Growing Pharma Services Opportunity with Full Suite of Molecular Analyses to Support Drug Development Conference Call …

Behavioral Health

Omada Mental Health Program Now Available at No Cost | PR Newswire | 4/6/2020

… stress, anxiety, and depression accessible at no cost for the next six months to all U.S.-based employers and commercial health plans. These organizations, and their covered populations, will now have access to behavioral health coaching powered by Omada’s technology to provide real human support and teach techniques that reduce symptoms. The offer comes as more than 60 percent of Americans have reported increased stress or anxiety due to Covid …

Patient Monitoring

VivaLNK scores CE mark for its multi-vital medical wearable sensor, SDK - plugilo.blog | MobiHealthNews | 12/4/2019

… for clinical trials, but there is a big difference between something that you truly use for clinical trials, to get clinical validation and real-world evidence and other wearables that are there for consumer use … is another major milestone in VivaLNK’s pursuit of delivering advanced patient monitoring solutions to market. VivaLNK’s unique electronic skin technology offers powerful technical capabilities without compromising user experience,” Jiang Li, CEO of VivaLNK, said in …

NIH

Identification and analysis of long non-coding RNA related miRNA sponge regulatory network in bladder urothelial carcinoma | 12/3/2019

… cancer. Conclusion Our findings provide an understanding of the important role of lncRNA–related ceRNAs in BUC. Additional experimental and clinical validations are required to support our findings. Background Bladder cancer (BC) is the most … were retrieved from The Cancer Genome Atlas (TCGA) database ( https://cancergenome.nih.gov/ ) in 2018. LncRNA, miRNA, and mRNAseq data were obtained using the Data Transfer Tool (provided by GDC Apps). Patient clinical information was also downloaded …

Digital Health

Lilly Names HealthVoyager as Winner of Digital Health Innovation Challenge for Inflammatory Bowel Disease (IBD) | PR Newswire | 12/2/2019

Lilly Names HealthVoyager as Winner of Digital Health Innovation Challenge for Inflammatory Bowel Disease (IBD) News provided by Eli Lilly and Company Dec 02, 2019, 07:22 ET INDIANAPOLIS , Dec. 2, 2019 /PRNewswire/ – Eli Lilly and … just a problem for patients and clinicians. As we finalize clinical validation of our solution, we can move to the business phase.” Lilly plans to conduct future innovation challenges in additional therapeutic areas in 2020 …

Mental Health

C2N Diagnostics to Report Results of APTUS™-Aβ Blood Test for Alzheimer’s Disease Brain Pathology | Business Wire | 12/2/2019

… Device Designation for the APTUS™-Aβ test from the US-FDA for this technology, and the company is working towards clinical validation and commercialization of the test. In addition to the diagnostic efforts, C 2 … Diagnostics KEYWORD: UNITED STATES NORTH AMERICA MISSOURI INDUSTRY KEYWORD: RESEARCH MENTAL HEALTH CLINICAL TRIALS OTHER HEALTH BIOTECHNOLOGY MANAGED CARE PHARMACEUTICAL HEALTH SCIENCE OTHER SCIENCE SOURCE: C2N Diagnostics, LLC …

Digital Health Solutions

Lilly Names HealthVoyager as Winner of Digital Health Innovation Challenge for Inflammatory Bowel Disease (IBD) | PR Newswire | 12/2/2019

… immersive educational experience for patients living with inflammatory bowel disease (IBD). At Lilly’s headquarters in Indianapolis , five finalists presented their digital health solutions aimed at transforming IBD care, during which an expert panel of judges … just a problem for patients and clinicians. As we finalize clinical validation of our solution, we can move to the business phase.” Lilly plans to conduct future innovation challenges in additional therapeutic areas in 2020 …

CDC

Lilly Names HealthVoyager as Winner of Digital Health Innovation Challenge for Inflammatory Bowel Disease (IBD) | PR Newswire | 12/2/2019

clinical validation of our solution, we can move to the business phase.” Lilly plans to conduct future innovation challenges in additional therapeutic areas in 2020. About Inflammatory Bowel Disease (IBD) Inflammatory bowel disease (IBD), with the two main types being ulcerative colitis and Crohn’s disease, is characterized by chronic inflammation of the digestive tract. 1 According to the CDC , approximately 3 million Americans have reported IBD. 2 IBD is an …

Breast Imaging

The latest AI breast cancer identification system, Transpara™ 1.6 will be showcased at RSNA 2019 | 11/30/2019

… The software uniquely ranks mammograms on a 10-point scale indicating the short term risk that cancer is present. Independent clinical validations demonstrate that this Transpara Exam Score can reduce workload and help radiologists prioritise … DBT) images from multiple vendors and is installed at leading breast imaging centers in Europe. Transpara is FDA Cleared for use with 2D mammography in the U.S. and is pending FDA Clearance for use with …

Medical Education

The latest AI breast cancer identification system, Transpara™ 1.6 will be showcased at RSNA 2019 | PRWeb | 11/29/2019

… The software uniquely ranks mammograms on a 10-point scale indicating the short term risk that cancer is present. Independent clinical validations demonstrate that this Transpara Exam Score can reduce workload and help radiologists prioritise … Volpara Health Technologies. Following the successful launch of ScreenPoint Medical’s medical education program at EUSOBI this year, ScreenPoint is collaborating with Siemens Healthineers for Transpara self-reading workshop sessions (10:15 - 5:00pm, Sunday 1 December -Thursday …

National Cancer Institute

The latest AI breast cancer identification system, Transpara™ 1.6 will be showcased at RSNA 2019 | PRWeb | 11/29/2019

… The software uniquely ranks mammograms on a 10-point scale indicating the short term risk that cancer is present. Independent clinical validations demonstrate that this Transpara Exam Score can reduce workload and help radiologists prioritise … 101 radiologists”, Rodriguez-Ruiz et al, JNCI: Journal of the National Cancer Institute, djy222, https://doi.org/10.1093/jnci/djy222 , 2019.. 2 “Detection of Breast Cancer with Mammography: Effect of an Artificial Intelligence Support System” Rodríguez …

Molecular Diagnostics

CCMB-ASPIRE NGS Team Recruitment : Non-NET Biotech / Life Sciences Apply | 11/28/2019

Job profile for Bio-Informatician to include in the NGS team @ ASPIRE @ CCMB ASPIRE – Association for Promoting Innovation & Research by Entrepreneurs Not for Profit Enterprise of CSIR-CCMB CCMB-ASPIRE Job Summary ASPIRE has actually been involved in providing molecular diagnostics services as well as clinical validation based on next-generation sequencing, to the public for over two decades. Responsibilities and Duties Co-ordinate with the laboratory personnel for preparing …

Medical Imaging

VUNO Presents the Future of Medical AI Solutions at RSNA 2019 | PR Newswire | 11/27/2019

… clinical validation, clinical application and regulatory approval to commercialization. Vuno’s future plans will be part of the talks in its effort to further improve the efficiency of overall clinical environments that include a variety of medical imaging-based diagnostic support systems, biosignals, and automatic speech recognition. In addition, its expansion plan to develop an optimal decision-making platform enabled by more accurate prediction of prognosis and treatment response will be …

Diagnostic Tests

Anixa Biosciences Announces Genesis Research to Join Cchek™ Prostate Cancer Study | PR Newswire | 11/26/2019

… advancing Anixa’s Cchek™ artificial intelligence driven liquid biopsy technology toward commercialization. Genesis Research will provide patient samples in support of clinical validation of Anixa’s Cchek™ Prostate Cancer Confirmation test. Study enrollment will be led by … of Cchek™ makes it a platform from which multiple cancer diagnostic tests may be developed. The first such test, a prostate cancer confirmation test, is slated for commercial launch by the end of 2019. Genesis …

HIPAA

Health Tech Trends: Connected Devices, Telehealth, Independent Living Solutions | 11/26/2019

… clinical validation, and seeking regulatory compliance with the FDA and HIPAA. Fitbit and Apple are leveraging their wearables platforms to develop diagnosis and monitoring algorithms. With CareKit, Apple is enabling care providers to develop apps on its platform rather than forcing a one-size fits all solution. This allows the process to be physician-led and physician-guided. Both Apple and Amazon are seeking to make their devices healthcare platforms …

Pfizer

STORM Therapeutics Appoints Dr. Josefin-Beate Holz as Chief Medical Officer | PR Newswire | 6/23/2020

… Bristol-Myers Squibb and LEO Pharma. Dr. Holz has worked on more than 50 disease targets at various stages of clinical validation across oncology, immunology and other indications. Commenting on today’s appointment, Dr Keith Blundy … backed by blue chip investors Cambridge Innovation Capital, M Ventures, Pfizer Ventures, Taiho Ventures LLC, Seroba Life Sciences and IP Group, who share the team’s ambitions to build a world-leading company in the field …

Bristol-Myers

STORM Therapeutics Appoints Dr. Josefin-Beate Holz as Chief Medical Officer | PR Newswire | 6/23/2020

Bristol-Myers Squibb and LEO Pharma. Dr. Holz has worked on more than 50 disease targets at various stages of clinical validation across oncology, immunology and other indications. Commenting on today’s appointment, Dr Keith Blundy , CEO of STORM Therapeutics said: “We are pleased to welcome Josefin to STORM. This is an exciting time as we accelerate the development of our lead programme, the first-in-class METTL3 inhibitor, into IND …

MacroGenics

MacroGenics Announces Publication in Science Translational Medicine Supporting Flotetuzumab Pivotal Study in Patients with Refractory Acute Myeloid Leukemia | Globe Newswire | 6/3/2020

Rockville, MD, June 03, MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced research published in the journal … forms the basis for a potential predictive biomarker for further clinical validation. About Flotetuzumab Flotetuzumab (also known as MGD006) is a clinical-stage bispecific DART molecule that recognizes both CD123 and CD3. CD123, the interleukin …

Compugen

Compugen Announces FDA Clearance of IND Application for Phase 1/2 Triple Combination Study of COM701 with Bristol Myers Squibb’s Opdivo® (Nivolumab) and TIGIT Inhibitor | PR Newswire | 6/1/2020

HOLON, Israel , June 1, Compugen Ltd. (NASDAQ: CGEN ), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today announced that the U.S. Food and Drug Administration has cleared the investigational new … 1 study evaluating our discovered target PVRIG, and the emerging clinical validation of the TIGIT pathway, leave us increasingly enthusiastic about our science-driven clinical approach evaluating these two complementary yet distinct pathways in combination …

Novartis

The Gross Law Firm Announces Class Actions on Behalf of Shareholders of GOSS, SERV and HALL | Yahoo News | 5/29/2020

clinical validation of Novartis’ oral DP2 antagonist; and (3) that, as a result of the foregoing, Defendants’ public statements were materially false and misleading at all relevant times. Shareholders may find more information at https://securitiesclasslaw.com/securities/gossamer-bio-inc-loss-submission-form/?id=7008&from=1 Servicemaster Global Holdings, Inc. ( SERV ) Investors Affected: February 26, 2019 - November 4, 2019 A class action has commenced on behalf of certain shareholders …

Johnson & Johnson

Sutro Biopharma Expands Senior Management with the Additions of Vice President of Clinical Development and Vice President of Finance and Controller | PR Newswire | 5/21/2020

… Director of Clinical Development at Exelixis and Senior Director of Clinical Development at Medivation (acquired by Pfizer). Dr. Berman has also held positions at Sunesis, Novacea, Cell Genesys, and Alza Pharmaceuticals (acquired by Johnson & Johnson). Dr. Berman received his M.D. from the University of Colorado Health Sciences Center and his B.A. in Chemistry from Northwestern University . “I have a long-standing interest and belief in Sutro’s technologies. Having spent most …

Merck

Xilio Therapeutics Appoints Martin H. Huber, M.D. as Chief Medical Officer | Business Wire | 4/27/2020

… GSK. While at Tesaro, he drove the expansion of the niraparib program and advanced the company’s immuno-oncology agents into the clinic. Prior to that, he was Vice President, Oncology Clinical Research at Merck Research Laboratories where he was instrumental in the advancement of Merck’s oncology programs, serving as program lead for pembrolizumab in non-small cell lung cancer. Prior to Merck, he served in roles of increasing responsibility at …

AliveCor

ERT Offers First Patient-Administered ECG Assessment for Continuation of Clinical Trials during COVID-19 | PRWeb | 4/23/2020

ERT Offers First Patient-Administered ECG Assessment for Continuation of Clinical Trials during COVID-19 Share Article Patients monitor cardiac safety at home with easy-to-use, FDA-cleared KardiaMobile 6L personal ECG KardiaMobile 6L Device By combining AliveCor’s advanced technology with our proven software and workflow platform, we are enabling our customers to continue developing new medical treatments during the COVID-19 pandemic, regardless of whether trial patients have …

SilverCloud Health

OSF Ventures Invests in Global Digital Behavioral Health Leader SilverCloud Health | PR Newswire | 4/13/2020

PEORIA, Ill., April 13, OSF Ventures, the corporate investment arm of OSF HealthCare, joined in a $16 million Series B funding round in SilverCloud Health , provider of accessible, scalable, digital behavioral health care solutions. Funding will be used to expand the Ireland -based company’s presence in the United States , along with an increased number of clinical trials to support enhancement of existing products and expansion of new offerings. OSF Ventures …

Biocept

Brazil Patent Granted for Biocept’s Target Selector™ Oncogene Mutation Enrichment and Detection Platform | PR Newswire | 4/9/2020

Sverige Brazil Patent Granted for Biocept’s Target Selector™ Oncogene Mutation Enrichment and Detection Platform Expands global intellectual property portfolio for highly sensitive methods of detecting cancer biomarkers in circulating tumor DNA (ctDNA) and other genetic … amounts of uninformative wild-type nucleic acid is eliminated. In clinical validation studies, Biocept has demonstrated, with a high degree of correlation, the ability to detect the same biomarkers in blood that were identified from …

AbbVie

C2N Diagnostics to Report Results of APTUS™-Aβ Blood Test for Alzheimer’s Disease Brain Pathology | Business Wire | 12/2/2019

clinical validation and commercialization of the test. In addition to the diagnostic efforts, C 2 N has developed a portfolio of anti-tau antibodies (including ABBV-8E12) for the treatment of Alzheimer’s Disease and other neurological disorders, and in March 2015 C 2 N formed a global partnership with AbbVie to develop and commercialize these antibodies. View source version on businesswire.com : https://www.businesswire.com/news/home/20191202005913/en/ CONTACT: Media Contact …

Celgene

Sutro Biopharma to Participate in the 31st Annual Piper Jaffray Healthcare Conference | PR Newswire | 11/26/2019

… product candidate to be evaluated in clinical trials resulting from Sutro’s XpressCF+™ technology platform. A third program, CC-99712 (BCMA-targeting ADC), which is part of Sutro’s collaboration with Bristol-Myers Squibb (formerly Celgene Corporation), recently began enrolling patients for its Phase I clinical trial of patients with multiple myeloma. Sutro’s proprietary technology was responsible for the discovery and manufacturing of CC-99712, for which Bristol-Myers Squibb has worldwide …

Fitbit

Health Tech Trends: Connected Devices, Telehealth, Independent Living Solutions | 11/26/2019

… clinical validation, and seeking regulatory compliance with the FDA and HIPAA. Fitbit and Apple are leveraging their wearables platforms to develop diagnosis and monitoring algorithms. With CareKit, Apple is enabling care providers to develop apps on its platform rather than forcing a one-size fits all solution. This allows the process to be physician-led and physician-guided. Both Apple and Amazon are seeking to make their devices healthcare platforms …

Apple Health

Health Tech Trends: Connected Devices, Telehealth, Independent Living Solutions | 11/26/2019

… clinical validation, and seeking regulatory compliance with the FDA and HIPAA. Fitbit and Apple are leveraging their wearables platforms to develop diagnosis and monitoring algorithms. With CareKit, Apple is enabling care providers to develop apps on its platform rather than forcing a one-size fits all solution. This allows the process to be physician-led and physician-guided. Both Apple and Amazon are seeking to make their devices healthcare platforms …

Thermo Fisher

InterVenn Biosciences Announces Positive Interim Clinical Trial Results and Appoints Biotech Veteran Klaus Lindpaintner, M.D. as Chief Scientific and Medical Officer | Business Wire | 11/18/2019

… news/home/20191118005886/en/ Klaus Lindpaintner, M.D. joins Intervenn Bio as Chief Scientific and Medical Officer (Photo: Business Wire) The clinical validation trial is currently ongoing in the United States, Malaysia, and the Philippines with … Human Genetics and Computational Biomedicine, four years as CSO at Thermo Fisher Scientific, and many years as Sr. VP and Head of the Roche Center for Medical Genomics, where he was intimately involved in Roche’s …

Guardant Health

Guardant Health Inc (GH) Q3 2019 Earnings Call Transcript | The Motley Fool | 11/11/2019

… GH earnings call for the period ending September 30, 2019. Nov 11, 2019 at 1:31AM Image source: The Motley Fool. Guardant Health Inc ( NASDAQ:GH ) Nov 7, 2019 , 4:30 p.m. ET Contents: Prepared Remarks: Operator … And then on LUNAR-1 obviously you’ve talked about the clinical validation for research use. You also talked about initiating a prospective adjuvant study for colorectal cancer. I guess what I’m really trying to get …

eMDs

Sutro Biopharma Reports Third Quarter 2019 Financial Results and Recent Business Highlights and Developments | PR Newswire | 11/8/2019

SOUTH SAN FRANCISCO, Calif. Sutro Biopharma, Inc. (NASDAQ: STRO ), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, today reported its financial results for the three and nine months ended September 30, 2019 . “In late October 2019 , we presented encouraging interim safety data from our Phase 1 trial for STRO-002 at the …

SWORD Health

The future of healthy aging | 10/31/2019

… the world, and validated them in more than 100 care sites across North America. In addition to financial support and clinical validation, CABHI provides innovators with acceleration services and access to its global networks of … in access to treatment. To overcome this barrier, Portuguese startup SWORD Health has created a digital platform that enables older adults to perform their physical therapy independently at home, under the remote watch of a …

ArQule

ArQule Reports Third Quarter 2019 Financial Results | Business Wire | 10/30/2019

BURLINGTON, Mass.- ArQule , Inc. (Nasdaq: ARQL) today announced its financial results for the third quarter of 2019. For the quarter ended September 30, 2019, the Company reported a net loss of $10.7 million, or $0.09 … access to certain technologies, selectivity/specificity, analytical validation, reproducibility, or clinical validation. Any delay or failure by our collaborators or ourselves to develop or obtain regulatory approval of companion diagnostics could delay or prevent approval …

Omada Health

New technologies for evidence-based care are boosting patient outcomes | Healthcare IT News | 9/6/2019

… clinical, behavioral, social and other health data. These panel members and presenters will include: Ashish Atreja, founder of NODE.Health , a clinical validation network that convenes academic innovation centers, clinicians, investors and entrepreneurs and deploys emerging … health outcomes through better medication adherence. Sean Duffy, CEO of Omada Health , who will demonstrate how its combination of health coaching, digital devices, peer groups and interactive lessons offer community and connection to help address …

Akili Interactive

World Digital Health Evidence Report 2019: Market Maturity, Current Gaps, and Needs | PR Newswire | 8/20/2019

… necessarily true from the report dataset. A number of solutions that play in the D2C space do not necessarily warrant clinical validation, and this was evident when D2C digital health companies and their products were … and SUD Companies SECTION 5 - A Final Thought Companies Mentioned Akili Interactive Labs AliveCor Calm HeartFlow iRhythm Technologies Mindmaze Omada Health Pear Therapeutics, Inc. Ro UCL VitalConnect For more information about this report visit https …

Propeller Health

Digital health is growing fast — but at what cost? | TechCrunch | 7/10/2019

… advocate interested in how new forms of health data are changing the relationship between physician and patient. As CCO of Propeller Health , he leads the company’s San Francisco office and oversees the pharma BD, health … there is a long road ahead of product development and clinical validation. When I look at a company like uBiome, which may have rushed its tests through physician approval to meet aggressive growth targets, I …

WellDoc

Digital health is growing fast — but at what cost? | TechCrunch | 7/10/2019

… patient than we are now. When I think of the early digital health companies — not just Propeller, but Omada Health, WellDoc, Ginger.io and Mango Health — all of their founders had an innate understanding of the … there is a long road ahead of product development and clinical validation. When I look at a company like uBiome, which may have rushed its tests through physician approval to meet aggressive growth targets, I …

Theranos

Digital health is growing fast — but at what cost? | TechCrunch | 7/10/2019

… standard. We touch people’s lives, often when they are at their most vulnerable. The healthcare startups in the news recently — Theranos, uBiome, Nurx, eClinicalWorks, Practice Fusion — seem to have lost sight of that crucial standard … there is a long road ahead of product development and clinical validation. When I look at a company like uBiome, which may have rushed its tests through physician approval to meet aggressive growth targets, I …

Qiagen

QIAGEN-DiaSorin Union to Enhance QuantFERON for Lyme Disease - June 6, 2019 - Zacks.com | 6/6/2019

QIAGEN N.V. ( QGEN - Free Report ) recently announced a development under its long-standing partnership with In Vitro Diagnostics (IVD) player, DiaSorin on QuantiFERON. This time, the alliance is set to invent an ultra-sensitive diagnostic test for Lyme disease on DiaSorin LIAISON Platforms. QIAGEN expects multi-site clinical validations for this new system during 2020 Lyme disease season. Regulatory submissions are expected at the end of 2020 in the United …

SVB Leerink

T2 Biosystems, Inc. (TTOO) CEO John McDonough on Q3 2019 Results - Earnings Call Transcript | Seeking Alpha | 11/12/2019

… W2O Group John McDonough - Chairman and CEO John Sprague - CFO Tom Lowery - Chief Scientific Officer Conference Call Participants Puneet Souda - SVB Leerink Partners Mark Massaro - Canaccord Genuity Paul Knight - Janney Montgomery Scott Steve Brozak - WBB … on that and see the data they published the demonstrated clinical validation of it. Steve Brozak Tom, if you might just answer one follow up on that, compared to the regular pathology and how labs …

Guardant Health Inc (GH) Q3 2019 Earnings Call Transcript | The Motley Fool | 11/11/2019

… to track. Mark Anthony Massaro – Canaccord Genuity Corp – Analyst Great. And then on LUNAR-1 obviously you’ve talked about the clinical validation for research use. You also talked about initiating a prospective adjuvant study for … final question comes from the line of Puneet Souda with SVB Leerink. Puneet Souda – SVB Leerink LLC Research Division – Analyst Helmy AmirAli , congrats on the quarter first of all. My first question is on LUNAR …

William Blair

Guardant Health Inc (GH) Q3 2019 Earnings Call Transcript | The Motley Fool | 11/11/2019

… up to questions. Operator? Questions and Answers: [Operator Instructions] Our first question comes from the line of Brian Weinstein with William Blair. Andrew Frederick Brackmann – William Blair – Analyst This is actually Andrew Brackmann on for … And then on LUNAR-1 obviously you’ve talked about the clinical validation for research use. You also talked about initiating a prospective adjuvant study for colorectal cancer. I guess what I’m really trying to get …

Guardant Health Inc (GH) CEO Helmy Eltoukhy on Q3 2019 - Earnings Call Transcript | Seeking Alpha | 11/9/2019

… and Chief Executive Officers AmirAli Talasaz – President and Co-Founder Derek Bertocci – Chief Financial Officer Conference Call Participants Andrew Brackmann – William Blair Tycho Peterson – JPMorgan Doug Schenkel – Cowen Derik De Bruin – Bank of America Mark … And then on LUNAR-1 obviously you’ve talked about the clinical validation for research use. You also talked about initiating a prospective adjuvant study for colorectal cancer. I guess what I’m really trying to get …

Rock Health

Digital endpoints library can aid clinical trials for new medicines - STAT | 11/6/2019

… trials. Rachel Murray/Getty Images A t nearly every major industry conference — from HLTH to CNS Summit , Exponential Medicine , and Rock Health Summit — speakers are talking about the benefits of decentralized clinical trials and digital … verification of the sensor, analytical validation of the algorithm and clinical validation of the measure itself are all necessary steps requiring different expertise. Precompetitive collaborations offer the most obvious solution to this barrier and have …

AI for all that ails American health care. But how smart is that? | Managed Care Magazine | 7/5/2019

… industry was beginning to ask what problems could AI solve. Now, one might wonder what AI isn’t trying to fix. Rock Health, a health technology investment and research company, reports that from 2011 to 2017 … not yet validated in real-world clinical settings. Real-world clinical validation, he argues, is important, because a model’s accuracy doesn’t guarantee it will work in a clinical setting and improve outcomes. No clinician involved …

Piper Jaffray

Deciphera Pharmaceuticals, Inc. (DCPH) CEO Steven Hoerter on Q3 2019 Results - Earnings Call Transcript | Seeking Alpha | 11/5/2019

… President, CEO & Director Matthew Sherman - Chief Medical Officer Tucker Kelly - CFO & Treasurer Conference Call Participants Jessica Fye - JPMorgan Christopher Raymond - Piper Jaffray Charles Zhu - Guggenheim Securities Eun Yang - Jefferies Jackson Harvey - Nomura Instinet Reni Benjamin … representing our first registration enabling data set and importantly strong clinical validation of our proprietary kinase switch control inhibitor platform and the potential for our product candidates to improve the lives of people with cancer …

OncoCyte Corporation (OCX) CEO William Annett on Q1 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/15/2019

… LifeSci Advisors William Annett - President and CEO Mitch Levine - CFO Lyndal Hesterberg - SVP, Research & Development Conference Call Participants Bill Quirk - Piper Jaffray Bruce Jackson - The Benchmark Company Casey Woodring - Janney Montgomery Scott Operator Good day … we will begin the final remaining steps prior to commercialization clinical validation. In the clinical validation study, we will analyze about 440 blinded, prospectively collected patient blood samples with the final confirmation of tests, sensitivity …

Baseline Ventures

Karuna Labs’ $3M seed round will support clinical validation of its VR chronic pain programs | MobiHealthNews | 9/18/2019

… Labs has raised $3 million in seed funding, the San Francisco startup announced last week. The funding was led by Baseline Ventures, with additional participation from Anorak Ventures, the AET Fund, the Hustle Fund, Correlation … IT’S FOR Karuna said that this funding will both support clinical validation studies of its VR product, and help the company further develop its technology and staff. MARKET SNAPSHOT Pain management has been a go …

VR startup Karuna Labs raises $3 million in seed funding to help over 30 million Americans suffering from chronic pain | 9/10/2019

… invasive surgeries. Today, Karuna Labs announced it has raised $3M in seed funding. The funding is going towards Karuna Labs’ clinical validation studies as well as further developing the company’s technology and medical/gaming team … brain, today announces $3 million in seed funding, led by Baseline Ventures, with investments from Anorak Ventures, the AET Fund, the Hustle Fund, Correlation Ventures, and Dreamit Ventures. “Karuna Labs is using immersive virtual reality …

Tiger Global Management

DotLab nets $10M for its blood test to diagnose endometriosis | FierceBiotech | 7/2/2019

… a patient’s response to therapy and recurrence over time. The series A proceeds will be used to further the test’s clinical validation, being conducted with researchers at Yale University, and to help bring on new … focuses on women’s health, fertility and genomics. Other backers included Tiger Global Management, Luxor Capital Group and the law firm Wilson Sonsini Goodrich & Rosati. “CooperSurgical brings significant operational resources and the opportunity to build upon …

DotLab nets $10M for its blood test to diagnose endometriosis | FierceBiotech | 7/2/2019

… a patient’s response to therapy and recurrence over time. The series A proceeds will be used to further the test’s clinical validation, being conducted with researchers at Yale University, and to help bring on new … focuses on women’s health, fertility and genomics. Other backers included Tiger Global Management, Luxor Capital Group and the law firm Wilson Sonsini Goodrich & Rosati. “CooperSurgical brings significant operational resources and the opportunity to build upon …

Khosla Ventures

Zebra Medical Vision Receives FDA Approval for World’s First AI Chest X-ray Triage Product | PR Newswire | 5/13/2019

… worklist systems, will be able to easily deploy our triage solution and improve their patients’ care and outcomes”. “In a clinical validation study we performed, Zebra-Med’s acute CXR pneumothorax and CT Brain bleed products … Eyal Toledano , Eyal Gura , and Elad Benjamin and funded by Khosla Ventures, Marc Benioff , Intermountain Investment Fund, OurCrowd Qure, Aurum, aMoon, Nvidia, J&J, and Dolby Ventures. Zebra Medical Vision has raised $50 million in …

SWORD Health Raises $8M in Series A Funding Round Led by Khosla Ventures to Redefine Physical Therapy and Musculoskeletal Care | Markets Insider | Business Insider | 4/16/2019

Khosla Ventures and several other prominent angel investors. It will allow SWORD to focus on bringing its technology to more patients’ homes and expand its footprint in the U.S. market. The investment will bring SWORD Health closer to its ultimate goal of cutting the costs of Musculoskeletal Disorders (MSDs) in the U.S. by half. The funding round will also allow the company to further expand the product’s clinical validation and …

Y Combinator

Meru Health raises $4.2M in Funding and Publishes Strong Clinical Outcomes | PR Newswire | 4/25/2019

… Y Combinator, Lifeline Ventures and IT-Farm. Meru Health, a Y Combinator 2018 company and currently participating in the Texas Medical Center TMCx Accelerator in Houston , has developed a licensed-clinician-supported, mobile phone-based digital therapeutic program for depression and anxiety. This financing will support additional clinical validation and preparation for larger scale rollout to health systems and large employers in several states across the U.S. “Having met with …

Digital mental health platform Meru Health snags $4.2M in seed funding | MobiHealthNews | 4/25/2019

Search Digital mental health platform Meru Health snags $4.2M in seed funding The startup plans to put the money towards additional clinical validation and rolling out the system to large health systems and employers. April 25, 2019 Share This morning, Finland and Palo Alto-based Meru Health, maker of a mental health platform, landed $4.2 million in seed funding. The new money comes from Freestyle Capital, Bonit Capital, Y Combinator

Freestyle Capital

Meru Health raises $4.2M in Funding and Publishes Strong Clinical Outcomes | PR Newswire | 4/25/2019

… Freestyle Capital, Bonit Capital, Y Combinator, Lifeline Ventures and IT-Farm. Meru Health, a Y Combinator 2018 company and currently participating in the Texas Medical Center TMCx Accelerator in Houston , has developed a licensed-clinician-supported, mobile phone-based digital therapeutic program for depression and anxiety. This financing will support additional clinical validation and preparation for larger scale rollout to health systems and large employers in several states across the …

Digital mental health platform Meru Health snags $4.2M in seed funding | MobiHealthNews | 4/25/2019

Search Digital mental health platform Meru Health snags $4.2M in seed funding The startup plans to put the money towards additional clinical validation and rolling out the system to large health systems and employers. April 25, 2019 Share This morning, Finland and Palo Alto-based Meru Health, maker of a mental health platform, landed $4.2 million in seed funding. The new money comes from Freestyle Capital, Bonit Capital, Y Combinator …

Medical Center

Cannabics Pharmaceuticals Appoints Dr. Erez Scapa, MD to its Scientific Board of Advisors | PR Newswire | 6/16/2020

TEL AVIV , Israel and BETHESDA, Maryland , June 16, Cannabics Pharmaceuticals Inc. (OTCQB: CNBX ), a leader in personalized cannabinoid medicine focused on cancer and its side effects, announced today that it has appointed Dr. Erez Scapa to its Scientific Board of Advisors. Dr. Scapa, an Expert in Invasive Gastroenterology in the Sourasky Medical Center in Tel-Aviv, Israel , will join the company’s scientific board of advisors, moving forward with the clinical …

University of Texas MD Anderson Cancer Center

Xilio Therapeutics Appoints Martin H. Huber, M.D. as Chief Medical Officer | Business Wire | 4/27/2020

… Hoffmann-La Roche and Rhone-Poulenc Rorer, where he led teams in the areas of oncology clinical development, drug safety and pharmacovigilance. He previously served as an Assistant Professor of Oncology at the University of Texas MD Anderson Cancer Center. Dr. Huber holds an M.D. from the Baylor College of Medicine. “I am thrilled to join a deeply experienced oncology drug development team at Xilio and help realize its important …

MD Anderson Cancer Center

Xilio Therapeutics Appoints Martin H. Huber, M.D. as Chief Medical Officer | Business Wire | 4/27/2020

… and Rhone-Poulenc Rorer, where he led teams in the areas of oncology clinical development, drug safety and pharmacovigilance. He previously served as an Assistant Professor of Oncology at the University of Texas MD Anderson Cancer Center. Dr. Huber holds an M.D. from the Baylor College of Medicine. “I am thrilled to join a deeply experienced oncology drug development team at Xilio and help realize its important mission of transforming …

Harvard Medical School

NuProbe Announced New Clinical Advisory Board Members from Yale and MD Anderson, Launched NGS Multi-gene Panels | PR Newswire | 4/22/2020

… of Texas MD Anderson Cancer Center and Abhijit Patel , M.D., Ph.D., from Yale University School of Medicine . These two new advisors join George M. Church , Ph.D., and David R. Walt , Ph.D., both from Harvard Medical School , on the NuProbe clinical advisory board, to advise on the product strategy and technology development of NuProbe. Meanwhile, NuProbe has recently launched the VarMap TM product line of two NGS multi-gene panels. “Liquid …

Perlmutter Cancer Center

How AI is improving cancer diagnostics | PR Newswire | 3/25/2020

… had finalized the case just on pathology, I would have been terribly wrong,” Snuderl says. The system Snuderl used is an early example of AI as a tool to diagnose cancer. NYU Langone’s Perlmutter Cancer Center received state approval to use its AI classifier as a diagnostic test in October 2019, and researchers around the world are developing similar systems to help pathologists diagnose cancer more accurately. The goal is …

University of Washington Medicine

C2N Diagnostics to Report Results of APTUS™-Aβ Blood Test for Alzheimer’s Disease Brain Pathology | Business Wire | 12/2/2019

… a single blood sample. In early 2019, C 2 N was granted Breakthrough Device Designation for the APTUS™-Aβ test from the US-FDA for this technology, and the company is working towards clinical validation and commercialization of the test. In addition to the diagnostic efforts, C 2 N has developed a portfolio of anti-tau antibodies (including ABBV-8E12) for the treatment of Alzheimer’s Disease and other neurological disorders …

Cleveland Clinic, Cleveland OH

Postdoctoral Fellowship | Nature | 11/26/2019

Lerner Research Institute, Cleveland Clinic Cleveland, OH, United States Posted about 2 hours 25, 2020 Metabolic Mechanisms and Translational Medicine Do you have a background in molecular, biochemical or chemical mechanisms yet are interested in … in endocrine regulation of inflammation in health and disease 2) Clinical validation in patients and clinical trials using innovative approaches 3) Animal models of advanced prostate cancer for translational and therapeutic studies 4) Identifying targets …

NYU Langone Health

First Molecular Test in the U.S. to Better Detect Brain Tumors Now Available to Patients | PR Newswire | 11/6/2019

NEW YORK , Nov. 6, 2019 /PRNewswire/ – NYU Langone Health and its Perlmutter Cancer Center have launched clinical whole genome DNA methylation profiling for patients with brain tumors . This leading-edge molecular assay utilizes DNA epigenetic … in the development of the methylation classifier and performed the clinical validation at NYU Langone. “Accurate diagnosis is a critical step in clinical care of patients with brain tumors,” says Erik P. Sulman , MD, PhD …

University Hospital

CardioFocus® Treats First Patients With HeartLight® Endoscopic Ablation System In France | PR Newswire | 10/29/2019

MARLBOROUGH, Mass. , Oct. 29, 2019 /PRNewswire/ – CardioFocus, Inc ., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that the first patients in France have been treated in the University Public Hospital of Nancy with the HeartLight Endoscopic Ablation System as part of an exclusive distribution partnership with MicroPort ® CRM France. To date, more than 7,000 patients have been successfully treated in the U.S., Europe …

Mayo Clinic

Mayo Clinic in the News Weekly Highlights for October 18, 2019 | 10/18/2019

Mayo Clinic in the News Weekly Highlights for October 18, 2019 By Emily Blahnik Editors: Emily Blahnik , Karl Oestreich Wall Street Journal , Amazon Joins Trend of Sending Workers Away for Health Care by Melanie Evans … Our Mayo office] is really for product development, technology development, clinical validation, all the things we can do with the Mayo Clinic that makes it so good for our company,” Londoner said. “We’ll be working …

Cleveland Clinic

Study Published in Journal of Clinical Investigation Insight Demonstrates Ability to Predict Early Rejection in Kidney Transplant with FractalDx Portfolio Technology | PR Newswire | 6/7/2019

… Transplant Surgeons (ASTS) and the American Society of Transplantation (AST). 2 Earlier this year, RenalytixAI initiated the planning process for clinical validation of the first diagnostic products from its FractalDx technology portfolio in-licensed from … Medicine, Mount Sinai Health System, University of Manatoba, Westmead Hospital, Cleveland Clinic, and University of Oxford. RenalytixAI intends to begin the clinical validation program for its acute transplant rejection diagnostic in H2 2019 and to …

Kaiser Permanente

Cleveland Diagnostics Announces Publication of Multicenter IsoPSA Clinical Validation Study Demonstrating Improved Accuracy Over Prostate-Specific Antigen Test | Business Wire | 5/7/2019

… in detecting high-grade prostate cancer. The study, led by Eric Klein, M.D., chairman of Cleveland Clinic’s Glickman Urological & Kidney Institute, involved leading researchers from Cleveland Clinic, Johns Hopkins, University of Texas Southwestern, Kaiser Permanente Northwest, Rabin Medical Center (Israel), and other academic and community clinical sites. “We now have extensive clinical evidence that supports our technology and the ability of IsoPSA to meaningfully change the current clinical paradigm in …

Penn Medicine

Genomic Health Presents New Data Demonstrating Value of Oncotype DX® to Optimize Breast Cancer Outcomes and Reduce Treatment Burden throughout Disease Continuum | PR Newswire | 12/11/2017

… neoadjuvant hormonal therapy alone could be an effective treatment strategy, resulting in BCS in 79 percent of cases. “This important clinical validation study demonstrates that analyzing tumor biology with Oncotype DX in the neoadjuvant setting … said Kevin R. Fox , M.D., director, Rena Rowan Breast Center, Penn Medicine. “By using the Recurrence Score and information based on the biology of each patient’s tumor, we are able to optimally manage their disease …

Colleen Cutcliffe

Pendulum Therapeutics Launches First Medical Probiotic For People With Type 2 Diabetes | PR Newswire | 6/4/2020

… Control “We’re taking a new approach to managing type 2 diabetes through the gut microbiome with Pendulum Glucose Control,” said Colleen Cutcliffe , Ph.D., CEO and co-founder of Pendulum Therapeutics. “Medical probiotics are a new … action and rapid translation from discovery and development through human clinical validation. Founded in 2012 by a diverse team of scientists with deep microbiology, biochemistry, computational and clinical expertise, Pendulum has raised $57 million to …

Eric Topol

Coronavirus Tests Value of Artificial Intelligence in Medicine | Medscape | 6/2/2020

… dangerous for patients, some AI experts warn. “AI is being used for things that are questionable right now,” said Dr. Eric Topol, director of the Scripps Research Translational Institute and author of several books on … systems are leery of rolling out a technology that requires clinical validation in the middle of a pandemic. Others say they didn’t need AI to deal with the coronavirus. Stanford Health Care is not using …

Anat Cohen-Dayag

Compugen Announces FDA Clearance of IND Application for Phase 1/2 Triple Combination Study of COM701 with Bristol Myers Squibb’s Opdivo® (Nivolumab) and TIGIT Inhibitor | PR Newswire | 6/1/2020

Anat Cohen-Dayag , Ph.D., President and CEO of Compugen. “The encouraging clinical data from the ongoing COM701 Phase 1 study evaluating our discovered target PVRIG, and the emerging clinical validation of the TIGIT pathway, leave us increasingly enthusiastic about our science-driven clinical approach evaluating these two complementary yet distinct pathways in combination with PD-1. Importantly, as the only company with wholly-owned clinical candidates against both PVRIG and …

Richard Gonnello

GOSSAMER DEADLINE ALERT: Faruqi & Faruqi, LLP Encourages Investors Who Suffered Losses Exceeding $50,000 Investing In Gossamer Bio, Inc. To Contact The Firm | PR Newswire | 5/22/2020

… rights, click here: www.faruqilaw.com/GOSS . There is no cost or obligation to you. You can also contact us by calling Richard Gonnello toll free at 877-247-4292 or at 212-983-9330 or by sending an e-mail … the reasons for Gossamer’s GB001 trial failures; (2) the purported clinical validation of Novartis’oral DP2 antagonist; and (3) as a result of the foregoing, Defendants’ public statements were materially false and misleading at all relevant …

Bill Newell

Sutro Biopharma Announces Encouraging Interim Phase 1 Clinical Data for a Dose Escalation Study of STRO-002 Antibody-Drug Conjugate in Ovarian Cancer | PR Newswire | 4/27/2020

… to discuss the STRO-002 data. “We designed STRO-002 to have a wider therapeutic window, with the potential for improved tumor control and better patient tolerability, than other FolRα targeted therapies,” said Bill Newell , CEO of Sutro Biopharma. “The data we present today from this all-comers trial suggest that our optimally designed ADC can achieve these objectives. In 75% (15 of 20) of ovarian cancer patients at STRO …

Kuldeep Singh Rajput

Digital Therapeutics Leader Biofourmis Expands into Oncology Market with Strategic Acquisition of Gaido Health | PR Newswire | 4/16/2020

… approach that continuously monitors patients’ physiology biomarkers and symptoms, detects early signs of complications, and arms care teams with tools to intervene early to prevent medical crises, improve outcomes and lower costs,” said Kuldeep Singh Rajput, CEO of Biofourmis. “The platform also empowers patients with cancer to self-manage symptoms using Biofourmis’ artificial intelligence [AI]-based Biovitals® treatment algorithms, which improves engagement and quality of life.” Gaido Health’s solution, which …

Michael Nall

Brazil Patent Granted for Biocept’s Target Selector™ Oncogene Mutation Enrichment and Detection Platform | PR Newswire | 4/9/2020

… technology, which increases our total patent portfolio to 39 as we continue to expand our global intellectual property protection,” stated Michael Nall , Biocept’s President and CEO. About Biocept’s ctDNA Target Selector™ Technology The “Switch-Blocker … amounts of uninformative wild-type nucleic acid is eliminated. In clinical validation studies, Biocept has demonstrated, with a high degree of correlation, the ability to detect the same biomarkers in blood that were identified from …

Sean Duffy

Omada Mental Health Program Now Available at No Cost | PR Newswire | 4/6/2020

… company’s proprietary digital care platform to provide interventions when participants need them the most. “We are living in a moment of collective, and unprecedented, stress and anxiety,” said Omada CEO and Co-Founder Sean Duffy . “Omada has the opportunity – and the ability – to deliver personalized support to people as they deal with the impact of a situation unlike anything we’ve experienced. Our coaches, and our digital care program, are uniquely …

Charlie O’Connell

Fitscript Offering GlucoseZone, Digital Exercise Treatment for Diabetics, for Free During COVID-19 Emergency | PRWeb | 3/27/2020

… and effectively exercise at home. “GlucoseZone was created for people living with diabetes as a way to ensure they can get the safe and effective exercise they need wherever they are located,” said Charlie O’Connell, founder of GlucoseZone and patient entrepreneur. “For this reason, we are providing GlucoseZone for free to people living with diabetes who can’t get access to gyms and fitness centers during this COVID-19 emergency. Diabetes …

Matija Snuderl

How AI is improving cancer diagnostics | PR Newswire | 3/25/2020

… in the same part of brain as before, and the biopsy seemed to confirm medulloblastoma. With this diagnosis, the girl would begin a specific course of radiotherapy and chemotherapy. But just as neuropathologist Matija Snuderl was about to sign off on the diagnosis and set her on that treatment path, he hesitated. The biopsy was slightly unusual, he thought, and he remembered a previous case in which what was thought …

Amit Kumar

Anixa Biosciences Announces Genesis Research to Join Cchek™ Prostate Cancer Study | PR Newswire | 11/26/2019

… advancing Anixa’s Cchek™ artificial intelligence driven liquid biopsy technology toward commercialization. Genesis Research will provide patient samples in support of clinical validation of Anixa’s Cchek™ Prostate Cancer Confirmation test. Study enrollment will be led by … potential for developing a liquid biopsy for detecting Prostate Cancer.” Amit Kumar , Ph.D., Chief Executive Officer of Anixa stated, “We are pleased to have Genesis Research join our expanding group of Cchek™ collaboration partners. Our …

Derek Maetzold

Castle Biosciences Shares Storm Higher After Quadrupling Q3 YoY Revenue | 11/13/2019

… Derek Maetzold, president and CEO of Castle Biosciences, commented, “We are pleased with our strong Q3/19 performance, driven by solid growth in our DecisionDx-Melanoma test report volume, which is a result of our investment in evidence development and scaling our commercial team in Q1/19…Based upon our results, we have decided to execute our commercial expansion plans in December 2019…We recently presented the clinical validation study data for …

Cameron Reynolds

VolitionRx Limited Announces Third Quarter 2019 Financial Results and Business Update | PR Newswire | 11/13/2019

… Eastern Time to discuss these results. Conference call details may be found below. An interview with Volition’s Chief Executive Officer, Cameron Reynolds Cameron Reynolds , President and Chief Executive Officer of Volition, upon releasing these results … strong progress in platform development, including the appointment of a Clinical Validation Expert with more than 15 years of experience in adapting assays to automated machines to greatly broaden our product platform range. Intellectual Property …

Matt Coffey

Oncolytics Biotech(R) Reports 2019 Third Quarter Financial Results and Operational Highlights | 11/12/2019

… Matt Coffey, President and CEO of Oncolytics Biotech. “The quarter was marked by continued clinical execution and additional clinical validation of our systemically delivered oncolytic virus, as we continued to advance two key clinical studies that will determine the design of the phase three program for pelareorep in metastatic breast cancer. First is the AWARE-1 study, which is enrolling patients and will report additional data before year end, and …

Brian Schwartz

ArQule Reports Third Quarter 2019 Financial Results | Business Wire | 10/30/2019

… of C481-mutant CLL patients. We are now actively recruiting patients in the multi-arm phase 2 trial,” commented Dr. Brian Schwartz, Chief Medical Officer of ArQule. “It is also very gratifying to have begun … access to certain technologies, selectivity/specificity, analytical validation, reproducibility, or clinical validation. Any delay or failure by our collaborators or ourselves to develop or obtain regulatory approval of companion diagnostics could delay or prevent approval …

Virgilio Bento

SWORD Health Wins Prestigious Health Award | PR Newswire | 10/14/2019

… people. “This award validates SWORD as the company that is leading innovation in the musculoskeletal space,” said CEO and founder Virgilio Bento . “To have a jury composed of the most brilliant people working in both … round in April this year, it is now focusing on clinical validation and expanding in the U.S. market. Logo: https://mma.prnewswire.com/media/829178/SWORD_Health_Logo.jpg SOURCE SWORD Health Related Links https://swordhealth.com …

Cameron Smith

Digestive Tracker FoodMarble Secures Clinical Validation | Business Wire | 8/22/2019

DUBLIN- FoodMarble, the Irish-based digital health company, has received clinical validation from a leading international digestive health research group. The start-up, which was founded in 2016, has developed a breakthrough device, AIRE, to … its 300,000 th breath test on the platform. Prof. David Cameron Smith, the Principal Investigator of the University of Auckland study, said : “Given FoodMarble’s substantially lower cost, its small size and the ability to test …

David Cameron

Digestive Tracker FoodMarble Secures Clinical Validation | Business Wire | 8/22/2019

DUBLIN- FoodMarble, the Irish-based digital health company, has received clinical validation from a leading international digestive health research group. The start-up, which was founded in 2016, has developed a breakthrough device, AIRE, to … registered its 300,000 th breath test on the platform. Prof. David Cameron Smith, the Principal Investigator of the University of Auckland study, said : “Given FoodMarble’s substantially lower cost, its small size and the ability to …

David Van Sickle

Digital health is growing fast — but at what cost? | TechCrunch | 7/10/2019

… research, they had answers, or a concrete plan to get answers. My first conversation with Propeller’s co-founder and CEO, David Van Sickle, was illustrative of this. I met David at the geekiest of health … there is a long road ahead of product development and clinical validation. When I look at a company like uBiome, which may have rushed its tests through physician approval to meet aggressive growth targets, I …

Heather Bower

DotLab nets $10M for its blood test to diagnose endometriosis | FierceBiotech | 7/2/2019

… clinical validation, being conducted with researchers at Yale University, and to help bring on new staff, the company said. RELATED: AbbVie puts endometriosis options on display in first Orilissa ad “The revolutionary technology behind DotLab’s endometriosis test could improve the lives of the hundreds of millions of women affected by this debilitating disease which has been under-researched and deprioritized for too long,” DotLab CEO Heather Bowerman said in a …

Chris Welsh

MDxHealth (R): Multi-center Study Validates SelectMDx’s High Negative Predictive Value and Sensitivity | Markets Insider | Business Insider | 6/10/2019

… BELGIUM - Jun 10, 2019 - MDxHealth SA (Euronext: MDXH.BR), a commercial-stage innovative molecular diagnostics company, today announced that a second clinical validation study demonstrating the performance of its liquid biopsy test SelectMDx for Prostate Cancer … Urology 2019 For more information: Consilium Strategic Communications Amber Fennell, Chris Welsh, David Daley UK: +44 20 3709 5701 [email protected] About MDxHealth MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic …

David Dale

MDxHealth (R): Multi-center Study Validates SelectMDx’s High Negative Predictive Value and Sensitivity | Markets Insider | Business Insider | 6/10/2019

… BELGIUM - Jun 10, 2019 - MDxHealth SA (Euronext: MDXH.BR), a commercial-stage innovative molecular diagnostics company, today announced that a second clinical validation study demonstrating the performance of its liquid biopsy test SelectMDx for Prostate Cancer … For more information: Consilium Strategic Communications Amber Fennell, Chris Welsh, David Daley UK: +44 20 3709 5701 [email protected] About MDxHealth MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to …

Michael Bell

CareDx, Inc. (CDNA) CEO Peter Maag on Q1 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/9/2019

… CDNA ) Q1 2019 Earnings Conference Call May 8, 2019 4:30 PM ET Company Participants David Clair - IR Peter Maag - CEO Michael Bell - CFO Conference Call Participants Bill Quirk - Piper Jaffray Brandon Couillard - Jefferies Per Ostlund … with antibody mediated rejection. Also in March we announced a clinical validation of AlloSure use in heart transplantation, which was published in the American Journal of Transplantation. This study is the first large prospective multi …

Brandon Couillard

CareDx, Inc. (CDNA) CEO Peter Maag on Q1 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/9/2019

… PM ET Company Participants David Clair - IR Peter Maag - CEO Michael Bell - CFO Conference Call Participants Bill Quirk - Piper Jaffray Brandon Couillard - Jefferies Per Ostlund - Craig-Hallum John Hsu - Raymond James Yi Chen - H.C. Wainwright … with antibody mediated rejection. Also in March we announced a clinical validation of AlloSure use in heart transplantation, which was published in the American Journal of Transplantation. This study is the first large prospective multi …

Peter Maag

CareDx, Inc. (CDNA) CEO Peter Maag on Q1 2019 Results - Earnings Call Transcript | Seeking Alpha | 5/9/2019

… CareDx, Inc. (NASDAQ: CDNA ) Q1 2019 Earnings Conference Call May 8, 2019 4:30 PM ET Company Participants David Clair - IR Peter Maag - CEO Michael Bell - CFO Conference Call Participants Bill Quirk - Piper Jaffray Brandon Couillard … with antibody mediated rejection. Also in March we announced a clinical validation of AlloSure use in heart transplantation, which was published in the American Journal of Transplantation. This study is the first large prospective multi …

New York, New York

Fern Health names Hewett Chiu as Chief Operating Officer | PR Newswire | 6/16/2020

NEW YORK Fern Health, a digital health company pioneering virtual musculoskeletal pain programs through employers, today announced the appointment of Hewett Chiu as Chief Operating Officer. Chiu brings diverse healthcare systems transformation and leadership experience to Fern, including more than three years at the New York City Department of Health & Mental Hygiene, where he oversaw the city’s $48M public mental health and primary care clinical integration initiative – the largest operation …

KidneyIntelX Receives New York State Approval to Commence Commercial Testing | 6/15/2020

New York State Department of Health (NYS DOH) to provide commercial testing of KidneyIntelX . The permit was granted following an extensive review by a panel of NYS DOH scientists and external reviewers of the analytical and clinical validation results for KidneyIntelX . Additionally, officials from the NYS DOH successfully completed an inspection of the RenalytixAI New York laboratory as part of this process, with no findings reported. Effective immediately, KidneyIntelX may …

State of New York

Fern Health names Hewett Chiu as Chief Operating Officer | PR Newswire | 6/16/2020

NEW YORK Fern Health, a digital health company pioneering virtual musculoskeletal pain programs through employers, today announced the appointment of Hewett Chiu as Chief Operating Officer. Chiu brings diverse healthcare systems transformation and leadership experience to Fern, including more than three years at the New York City Department of Health & Mental Hygiene, where he oversaw the city’s $48M public mental health and primary care clinical integration initiative – the largest operation …

KidneyIntelX Receives New York State Approval to Commence Commercial Testing | 6/15/2020

New York State Department of Health (NYS DOH) to provide commercial testing of KidneyIntelX . The permit was granted following an extensive review by a panel of NYS DOH scientists and external reviewers of the analytical and clinical validation results for KidneyIntelX . Additionally, officials from the NYS DOH successfully completed an inspection of the RenalytixAI New York laboratory as part of this process, with no findings reported. Effective immediately, KidneyIntelX may …

York, Pennsylvania

Fern Health names Hewett Chiu as Chief Operating Officer | PR Newswire | 6/16/2020

NEW YORK Fern Health, a digital health company pioneering virtual musculoskeletal pain programs through employers, today announced the appointment of Hewett Chiu as Chief Operating Officer. Chiu brings diverse healthcare systems transformation and leadership experience to Fern, including more than three years at the New York City Department of Health & Mental Hygiene, where he oversaw the city’s $48M public mental health and primary care clinical integration initiative – the largest operation …

KidneyIntelX Receives New York State Approval to Commence Commercial Testing | 6/15/2020

York State Department of Health (NYS DOH) to provide commercial testing of KidneyIntelX . The permit was granted following an extensive review by a panel of NYS DOH scientists and external reviewers of the analytical and clinical validation results for KidneyIntelX . Additionally, officials from the NYS DOH successfully completed an inspection of the RenalytixAI New York laboratory as part of this process, with no findings reported. Effective immediately, KidneyIntelX may now …

Boston, Massachusetts

Facebook cofounder Saverin’s B Capital just closed its third flagship fund with $822 million | TechCrunch | 6/30/2020

… with $360 million in capital commitments in 2016.) All three funds count as an anchor investor the management consulting giant Boston Consulting Group, where Ganguly was an advisor for several years and with which the … an eight-year-old, San Mateo, Calif. company that provides clinical validation of health apps and that is expanding into Asia with the help of B Capital. B Capital, which has two partners in San …

Facebook cofounder Saverin’s B Capital just closed its third flagship fund with $822 million | TechCrunch | 6/30/2020

… raised for its $360 million debut effort in 2016. Both funds count as an anchor investor the management consulting giant Boston Consulting Group, where Ganguly was an advisor for several years and with which the … an eight-year-old, San Mateo, California company that provides clinical validation of health apps and that is expanding into Asia with the help of B Capital. B Capital, which has two partners in San …

State of Maryland

Cannabics Pharmaceuticals Appoints Dr. Erez Scapa, MD to its Scientific Board of Advisors | PR Newswire | 6/16/2020

TEL AVIV , Israel and BETHESDA, Maryland , June 16, Cannabics Pharmaceuticals Inc. (OTCQB: CNBX ), a leader in personalized cannabinoid medicine focused on cancer and its side effects, announced today that it has appointed Dr. Erez Scapa to its Scientific Board of Advisors. Dr. Scapa, an Expert in Invasive Gastroenterology in the Sourasky Medical Center in Tel-Aviv, Israel , will join the company’s scientific board of advisors, moving forward with the clinical …

Cannabics Pharmaceuticals Appoints Dr. Erez Scapa, MD to its Scientific Board of Advisors | 6/16/2020

Maryland , June 16, 2020 /PRNewswire/ – Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, announced today that it has appointed Dr. Erez Scapa to its Scientific Board of Advisors. Dr. Scapa, an Expert in Invasive Gastroenterology in the Sourasky Medical Center in Tel-Aviv, Israel , will join the company’s scientific board of advisors, moving forward with the clinical validation of the …

San Diego, California

Coronavirus Tests Value of Artificial Intelligence in Medicine | Medscape | 6/2/2020

… 19 news and guidance in Medscape’s Coronavirus Resource Center. Dr. Albert Hsiao and his colleagues at the University of California-San Diego health system had been working for 18 months on an artificial intelligence program … systems are leery of rolling out a technology that requires clinical validation in the middle of a pandemic. Others say they didn’t need AI to deal with the coronavirus. Stanford Health Care is not using …

Coronavirus tests the value of artificial intelligence in medicine | FierceHealthcare | 5/27/2020

… systems to accelerate promising applications. (Ryzhi/Getty Images) Albert Hsiao, M.D., Ph.D., and his colleagues at the University of California San Diego (UCSD) health system had been working for 18 months on an artificial intelligence … systems are leery of rolling out a technology that requires clinical validation in the middle of a pandemic. Others say they didn’t need AI to deal with the coronavirus. Stanford Health Care is not using …

State of California

Sera Prognostics Appoints Thomas J. Garite, M.D. as Vice President of Clinical Sciences - Business Wire | 6/24/2020

… and Maternal-Fetal Medicine and a recently retired Edward H. Quilligan Professor of Obstetrics and Gynecology at the University of California at Irvine. Dr. Garite served 18 years as this Department’s Chairman, and now holds … preterm birth, preeclampsia, gestational diabetes, growth restriction, and others). Rigorous clinical validation of PreTRM® test performance (accuracy of predicting premature delivery) was reported in the American Journal of Obstetrics & Gynecology in 2016 in a US …

Coronavirus Tests Value of Artificial Intelligence in Medicine | Medscape | 6/2/2020

… COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Dr. Albert Hsiao and his colleagues at the University of California-San Diego health system had been working for 18 months on an artificial intelligence … systems are leery of rolling out a technology that requires clinical validation in the middle of a pandemic. Others say they didn’t need AI to deal with the coronavirus. Stanford Health Care is not using …

Chicago, Illinois

$SEOVF Sernova Highlights Positive Results Presented at the American Diabetes Association’s Virtual 80th Scientific Sessions - OTC Dynamics | 6/18/2020

… SVA) (OTC:SEOVF) (FSE:PSH), a clinical-stage regenerative medicine therapeutics company, highlights positive results from its submitted abstract entitled “Clinical Validation of the Implanted Pre-Vascularized Cell Pouch(TM) as a Viable, Safe Site … Phase I/II human clinical study at the University of Chicago. In both clinical studies, patients with T1D were implanted with both sentinel (small devices removed to assess cell survival) and larger therapeutic devices, anywhere …

Sernova Highlights Positive Results Presented at the American Diabetes Association’s Virtual 80th Scientific Sessions | The Wapakoneta Daily News | 6/18/2020

… SVA ) ( OTC:SEOVF ) (FSE:PSH ), a clinical-stage regenerative medicine therapeutics company, highlights positive results from its submitted abstract entitled “Clinical Validation of the Implanted Pre-Vascularized Cell Pouch(TM) as a Viable, Safe Site … Phase I/II human clinical study at the University of Chicago. In both clinical studies, patients with T1D were implanted with both sentinel (small devices removed to assess cell survival) and larger therapeutic devices, anywhere …