Vysioneer Inc. has won the FDA’s nod for its Vbrain artificial intelligence (AI)-powered tumor autocontouring software. The company said Vbrain is the first AI device to receive FDA clearance for tumor autocontouring in radiation therapy. Vbrain is a neural network-based AI solution, trained from clinical data. Read More
Pixium Vision SA reported that its merger with Second Sight Medical Products Inc. has foundered. The combination would have eased Paris-based Pixium’s entry into the U.S. market and Sylmar, Calif.-based Second Sight’s access to the European market, which Pixium has previously opposed, and enabled them to jointly develop and market neuromodulation devices that restore some degree of vision to the blind. The deal had been expected to close early in the second quarter of 2021. Read More
Device reprocessing has intermittently prompted FDA action in an effort to tamp down on infection-driven adverse events for various types of endoscopes, and the latest spate of events involves endoscopes used in urological applications. While the three associated fatalities all took place outside the U.S., the FDA nonetheless indicated that it is considering the possibility that a device redesign is in order, a move the agency endorsed in connection with infections blamed on duodenoscopes. Read More
Nearly 16,500 groups and individuals put in their two cents on a proposed National Institute of Standards and Technology (NIST) rule clarifying that the U.S. government, under the Bayh-Dole Act, can’t march in on patents derived from federally funded research just because it doesn’t consider the price of the resulting product “reasonable.” Read More
The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats. Read More
New hires and promotions in the med-tech industry, including: Biomagnetic Sciences, Cardiac Dimensions, Dascena, Intersect ENT, Second Sight Medical, Vivasure. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcam, Avacta, Applied Spectral Imaging, Biotome, Brainchip, Critical Transport Solutions Australia, Cryoport, Eurofins Viacor, Heartflow, Kromatid, Masimo, Motus GI, Novel Microdevices, Oncimmune, Ortho Regenerative Technologies, Roche. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips, Roche. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies. Read More
Keeping you up to date on recent developments in oncology, including: Popcorn-like gold nanofilms for detection of miRNA in cancer; Myeloid cells differ in primary and recurrent glioblastoma; Premetastatic niche is prepared via leaky gut in colorectal cancer; Brain metastases of breast cancer depend on fatty acid synthesis. Read More
