Two-year results from the Evolut Low Risk Trial show Medtronic plc’s Evolut transcatheter aortic valve replacement (TAVR) is noninferior to open-heart surgery in younger, healthier aortic stenosis patients. Moreover, the Evolut cohort fared better on certain critical events. Specifically, two-year rates of all-cause mortality or disabling stroke were 4.3% for TAVR patients vs. 6.3% for those undergoing surgical aortic valve repair (SAVR). Read More
Percutaneously implanted devices designed to seal off the left atrial appendage (LAA) have been around for some time, but a recent study of surgical closure of the appendage might have a beneficial effect on sales of these devices despite that the study did not deal directly with these devices. The results were compelling enough to provoke a halt to the study before all patients had reached the projected term of follow-up, and at least one observer said it may be time to study whether more routine use of devices for percutaneous LAA closure is indicated. Read More
The FDA’s legal authority to regulate lab-developed tests (LDTs) has come into question on several occasions in a number of venues, and the issue is enjoying new life yet again thanks to more activity on Capitol Hill. While two competing pieces of legislation are back in play, the most critical question may be whether the FDA has any authority left at all after the August 2020 rescission letter from the Department of Health and Human Services. Read More
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR). Read More
While the founder of Woebot Health says that the app is not intended to replace human therapists, for the majority of the world who cannot locate an available psychologist or afford one once found, Woebot aims to offer a “radically accessible” option for mental health care. Read More
New hires and promotions in the med-tech industry, including: Atonarp, Camber Spine, Corvent, Cutera, Vascular Dynamics, Viewpoint Molecular. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Boston Scientific, Diadem, Heartflow, Novocure, Stratus Medical, Ultromics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avisa Diagnostics, Binx Health, Bio-Teche, Discovery Life Sciences, Fogchain, Medline Industries, Seegene, Sherlock Biosciences, Targos Molecular Pathology, Teleflex, Water Street Healthcare Partners. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Corvent Medical, Ice Neurosystems, Nexstim, Wise. Read More
