| 5/18/2022 |
Video-based Physiologic Monitoring: Promising Applications for the ICU and Beyond |
Nature |
... Non-contact, video-based methods present a more flexible and information-dense alternative that may enable creative improvements to patient care. Still, these approaches are susceptible to several sources of bias and require rigorous clinical validation . A recent study by Jorge et al. demonstrates that video-based monitoring can reliably capture heart rate and respiratory rate and overcome many potential sources of bias in post-operative settings. This presents real ... |
| 5/16/2022 |
Diadem Announces Publication of Clinical Study Confirming Its AlzoSure® Predict Blood Test Can Accurately Predict Progression to Alzheimer's Disease Six Years Before Diagnosis |
PR Newswire |
... than PET Amyloid Imaging——AlzoSure Predict Is an FDA-Designated Breakthrough Device and CE-IVD Marked in the E.U. —MILAN , May 16, Diadem SpA today announced publication of the results of a clinical validation study of its AlzoSure ® Predict prognostic blood test for Alzheimer's disease (AD). The article, A Conformational Variant of p53 (U-p53AZ) as Blood-Based Biomarker for the Prediction of the Onset of Symptomatic ... |
| 5/16/2022 |
Veracyte Announces New Data Reinforcing Percepta Nasal Swab Test's Clinical Performance and Utility in Lung Cancer Risk Assessment | Business Wire |
Business Wire |
... nodules were found incidentally, as well as through screening.”For the study, researchers evaluated data from a subset of 291 current and former smokers with lung nodules who were part of the original clinical validation study for the Percepta Nasal Swab test. Among these individuals, 213 (73%) met USPSTF screening criteria (pack years ≥20, years since quit 15, age 50-80 years), while 78 (27%) did not. Researchers compared ... |
| 5/16/2022 |
Eliem Therapeutics Reports First Quarter Financial and Business Highlights |
Yahoo News |
... of ETX-810 in diabetic peripheral neuropathic pain, we look forward to providing the topline Phase 2a data for ETX-810 in lumbosacral radicular pain, the chronic pain indication with the most robust precedent clinical validation for this mechanism, in the third quarter of 2022. In addition to ETX-810, we remain committed to the development of our ETX-155 program in depression and epilepsy and will provide an update ... |
| 5/16/2022 |
Eliem Therapeutics Reports First Quarter Financial and |
Globe Newswire |
... of ETX-810 in diabetic peripheral neuropathic pain, we look forward to providing the topline Phase 2a data for ETX-810 in lumbosacral radicular pain, the chronic pain indication with the most robust precedent clinical validation for this mechanism, in the third quarter of 2022. In addition to ETX-810, we remain committed to the development of our ETX-155 program in depression and epilepsy and will provide an update ... |
| 5/16/2022 |
Eliem Therapeutics Reports First Quarter Financial and Business Highlights | Insider Tracking |
insidertracking.com |
... of ETX-810 in diabetic peripheral neuropathic pain, we look forward to providing the topline Phase 2a data for ETX-810 in lumbosacral radicular pain, the chronic pain indication with the most robust precedent clinical validation for this mechanism, in the third quarter of 2022. In addition to ETX-810, we remain committed to the development of our ETX-155 program in depression and epilepsy and will provide an update ... |
| 5/16/2022 |
Eliem Therapeutics Reports First Quarter Financial and Business Highlights |
onenewspage.com |
... of ETX-810 in diabetic peripheral neuropathic pain, we look forward to providing the topline Phase 2a data for ETX-810 in lumbosacral radicular pain, the chronic pain indication with the most robust precedent clinical validation for this mechanism, in the third quarter of 2022. In addition to ETX-810, we remain committed to the development of our ETX-155 program in depression and epilepsy and will provide an update ... |
| 5/14/2022 |
Considerations for artificial intelligence clinical impact in oncologic imaging: an AI4HI position paper - PubMed |
National Institutes of Health |
... appropriate validation methodology, adequate ground truth, and careful selection of clinical endpoints. Endpoints may be pathology hallmarks, disease behavior, treatment response, or patient prognosis. Ensuring ethical, safety, and privacy considerations are also mandatory before clinical validation is performed. The Artificial Intelligence for Health Imaging (AI4HI) Clinical Working Group has discussed and present in this paper some indicative Machine Learning (ML) enabled decision-support solutions currently under research in the AI4HI ... |
| 5/13/2022 |
Whats's the future of digital medicines? Find out at INVEST PharmaTech. |
MedCity News |
Digital medicine adoption, also referred to as digital therapeutics, was challenging ahead of the pandemic. Clinical validation and FDA clearances have gradually moved the needle on how these treatments are perceived. But the need for remote patient monitoring for chronic conditions during the Covid-19 pandemic has led to increased interest in this area with the hope that it will continue to climb beyond the pandemic.Many of the digital ... |
| 5/12/2022 |
Leaders say 4 key strategies will speed up bringing new drugs to market | Fortune |
Fortune |
... health care industry to move more quickly.Leaders in health care recently discussed solutions for speeding up the therapeutic process at Fortune 's Brainstorm Health conference .I think the technology is moving faster than the clinical validation we can do for them. We have to ensure we don’t get left behind, said Dr. Samit Hirawat , executive vice president and chief medical officer at Bristol Myers Squibb .Hirawat appeared on a ... |
| 5/12/2022 |
Leaders say 4 key strategies will speed up bringing new drugs to market |
Fortune |
... health care industry to move more quickly.Leaders in health care recently discussed solutions for speeding up the therapeutic process at Fortune 's Brainstorm Health conference .I think the technology is moving faster than the clinical validation we can do for them. We have to ensure we don’t get left behind, said Dr. Samit Hirawat , executive vice president and chief medical officer at Bristol Myers Squibb .Hirawat appeared on a ... |
| 5/12/2022 |
Enrollment Completed in Reflow Medical's DEEPER OUS Clinical Trial | Business Wire |
Business Wire |
... continues, “The fact that it does so without leaving anything behind means the patient avoids the risk of complications from the use of a stent.”“Completing enrollment is a significant milestone in the clinical validation and regulatory pathway to approval of the Spur Stent System to treat patients,” said Teo Jimenez, Vice President of Research and Development for Reflow Medical.Isa Rizk, CEO and Co-Founder of Reflow ... |
| 5/12/2022 |
Enrollment Completed in Reflow Medical's DEEPER OUS Clinical Trial |
Business Wire |
... continues, “The fact that it does so without leaving anything behind means the patient avoids the risk of complications from the use of a stent.”“Completing enrollment is a significant milestone in the clinical validation and regulatory pathway to approval of the Spur Stent System to treat patients,” said Teo Jimenez, Vice President of Research and Development for Reflow Medical.Isa Rizk, CEO and Co-Founder of Reflow ... |
| 5/12/2022 |
Cellectis Provides Business Update and Reports Financial |
Globe Newswire |
ó¶ UCART20x22 preclinical data presented at AACR demonstrated PoC with robust in vitro and in vivo anti-tumor activity‚ó¶ Published two articles in Nature Communications providing preclinical validation for the evaluation of UCART123 to treat AML and BPDCN‚ó¶ Received a $20 million convertible note under collaboration agreement with its partner Cytovia Therapeutics‚ó¶ The US FDA has allowed an IND to proceed for Iovance Biotherapeutics‚Äô first genetically ... |
| 5/12/2022 |
Enrollment Completed in Reflow Medical's DEEPER OUS Clinical Trial |
Yahoo News |
... He continues, "The fact that it does so without leaving anything behind means the patient avoids the risk of complications from the use of a stent.""Completing enrollment is a significant milestone in the clinical validation and regulatory pathway to approval of the Spur Stent System to treat patients," said Teo Jimenez, Vice President of Research and Development for Reflow Medical.Isa Rizk, CEO and Co-Founder of Reflow Medical ... |
| 5/11/2022 |
Helping Digital Health Companies Get Regulatory Approval: Interview with M Disrupt CEO Ruby Gadelrab |
fuentitech.com |
Digital health companies often have a hard time knowing where to start for regulatory approval. Issues such as conducting clinical validation studies and finding the right regulatory experts to support their journey can all pose significant hurdles. Due to these difficulties, Ruby Gadelrab founded M Disrupt, a digital health intelligence company based in California.The company helps early-stage digital health companies seek regulatory approval by connecting with a large ... |
| 5/11/2022 |
Cleveland Diagnostics Announces Inclusion of IsoPSA® in National Comprehensive Cancer Network® Guidelines for Prostate Cancer Early Detection |
Business Wire |
... consensus, now includes our IsoPSA test in its guidelines for prostate cancer early detection,” said Arnon Chait, Ph.D., Chief Executive Officer at Cleveland Diagnostics. “The NCCN’s new recommendation highlights years of extensive clinical validation and clinical utility studies that all point to how IsoPSA could change the way prostate cancer is diagnosed and subsequently treated.”“Most urologists follow NCCN prostate cancer guidelines as a standard in the ... |
| 5/11/2022 |
Cleveland Diagnostics Announces Inclusion of IsoPSA® in National Comprehensive Cancer Network® Guidelines for Prostate Cancer Early Detection | Business Wire |
Business Wire |
... consensus, now includes our IsoPSA test in its guidelines for prostate cancer early detection,” said Arnon Chait, Ph.D., Chief Executive Officer at Cleveland Diagnostics. “The NCCN’s new recommendation highlights years of extensive clinical validation and clinical utility studies that all point to how IsoPSA could change the way prostate cancer is diagnosed and subsequently treated.”“Most urologists follow NCCN prostate cancer guidelines as a standard in the ... |
| 5/11/2022 |
Brightseed Closes $68M To Accelerate A.I.-Led Exploration of Nature for Health Solutions |
healthtechnologynet.com |
... nature and human health, today announced $68 million in Series B funding led by Temasek, with participation from existing and new investors. The new funding will enable Brightseed to advance natural compound discovery and clinical validation , and launch the company’s first FDA-GRAS ingredient from a new commercialization center in Raleigh, North Carolina.“Nature holds an incredibly rich and largely uncharted source of powerful, natural bioactives that create health ... |
| 5/10/2022 |
Global Non-Invasive Prenatal Testing Market is expected to |
Globe Newswire |
... The Discovery of cell-free DNA (cfDNA)-based NIPT has created a rapid shift in the paradigm of aneuploidy screening during pregnancy. It’s a simple blood test that can be performed during pregnancy. Clinical validation studies suggest that NIPT is more accurate than combined first-trimester screening (CFTS), with very high sensitivity (99.3%) and specificity (99.9%) for trisomy 21(Down syndrome). NIPT is also safer than other invasive diagnostic ... |