Last year, artificial intelligence (AI)-focused Caption Health Inc. won the U.S. FDA’s nod for software that guides untrained clinicians step-by-step in providing a cardiac ultrasound exam, a process normally performed by a highly skilled specialist. Now, the Brisbane, Calif.-based company has published data showing nurses without prior ultrasound experience who used Caption Guidance software captured ultrasound images of diagnostic quality to assess known cardiac conditions. Read More
The Washington Legal Foundation’s (WLF) webinar on False Claims Act (FCA) litigation highlighted several developments in case law, including that non-relator FCA cases were up significantly in fiscal year 2020. However, Jay Stephens, an attorney with Kirkland & Ellis LLP, noted that Sen. Chuck Grassley (R-Iowa) has taken aim yet again at the materiality standard for false claims as spelled out in the Supreme Court’s Escobar, a move which if successful could amplify the federal enforcement focus on life science companies. Read More
Patensee Ltd. initiated a first-in-human trial of its machine vision-based surveillance system for stenosis in hemodialysis patients. The trial will evaluate the imaging system's ability to perform contact-free surveillance of the access points or fistulas essential for dialysis, which nearly all narrow or become blocked over time. The surveillance system aims to mimic the central components of a dialysis nurse's exam using technology. Read More
PERTH, Australia – About seven years ago, Australia’s George Institute for Global Health conducted a study to find out how many people require dialysis for end-stage kidney failure compared to how many people receive treatment. Read More
TORONTO – Puzzle Medical Devices Inc. has been granted a U.S. FDA breakthrough device designation for a transcatheter heart pump designed for fragile patients with few minimally invasive options for treating advanced heart failure. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied DNA Sciences, Flurotech, Hudson Robotics, Illumina, Luminex, Nanomix, Obviohealth, Vivalnk. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bio-Rad. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: White House names pick for CMS administrator’s post; FDA posts advisory for pulse oximetry; CDC: Telehealth visits dropped over last half of 2020; CRS says user fee shares of total review costs on the rise; Federal Circuit kicks case back to PTAB. Read More
Keeping you up to date on recent developments in neurology, including: Deep brain stimulation prevents epileptic seizures in mouse model; Researchers discover promising biomarkers to diagnose mild TBI; New information on how antidepressants affect the brain uncovered. Read More
