The FDA has approved Medtronic plc’s Evolut FX TAVR system for patients with symptomatic severe aortic stenosis. During Medtronic’s fiscal first quarter earnings call CEO Geoffrey Martha said the company will roll the latest generation system out in the U.S. market later this year, with a full launch planned in 2022. Read More
Better Therapeutics Inc. has closed on a $50 million debt facility that advances the company’s push into the market for digital therapeutics for type 2 diabetes, a market that seems poised to expand drastically in the next few years. The $50 million debt facility by Hercules Capital is just one of several important financial benchmarks for Better, which is also planning to go public thanks to a merger with a special purpose acquisition company (SPAC) that may raise well in excess of $100 million, all of which seem to promise a bright future for Better and those with type 2 diabetes. Read More
LONDON – Endomag Ltd. has received endorsement from the U.K. health technology assessment body NICE, opening the way to broader adoption of its Magtrace non-radioactive cancer staging technology in the National Health Service, and providing backing for commercialization of the system in other markets. Read More
PARIS – A consortium led by French clinical and scientific experts has just published results in the Journal of Experimental Medicine of a study showing the contribution of a new simplified diagnostic test in better identifying the level of contagiousness of subjects infected with SARS-CoV-2. Read More
The U.S. National Institutes of Health (NIH) said it has developed a novel method of sample preparation for tests for the SARS-CoV-2 virus, which could trim time and costs for diagnostic testing for COVID-19. This approach bypasses the RNA extraction step, thus eliminating the need for some supplies, and NIH said this technique is available for co-development or licensing with the private sector, giving the smart testing company access to a patent-protected technology with an existing demand already built in. Read More
Johnson & Johnson has announced new data supporting use of its COVID-19 vaccine as a booster shot, after separate trial data from the U.K. showed effects of several vaccines waned after six months. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott Laboratories, Alpha Healthcare, Anatomage, Baylis, Bioaesthetics, Biosyent, Boston Scientific, Elekta, Healthcare Services Group, Helius Medical Technologies, Humacyte, ID Genomics, Iotron Medical Meadowlands Diagnostics, Osteoid, Photocure, Provista Diagnostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aatru Medical, Cellmax Life. Read More