Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied DNA Sciences, Astrotech, Atai Life Sciences, Breathtech, Johnson & Johnson Vision, Manta, Medical Information Technology, Menicon, Natera, Newomics, Nicoya Lifesciences, Opsens, Psyber, Premier Medical, Qiagen, Roche, Titan Health & Security Technologies, Vizient.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acarix, Akili Interactive, Boston Scientific, Cardiac Dimensions, Lumithera, Medcura, Pixium Vision, Protokinetix.
Med-tech firms raising money in public or private financings, including: Bausch Health, Better Therapeutics, CA Healthcare, Carta Healthcare, CM Life Sciences III, Firefly Health, Lumiradx, Mountain Crest, Orchid, Phreesia, Privia Health Group, Vizgen.
Keeping you up to date on recent developments in orthopedics, including: New study expands evaluation of gene therapy for spinal muscular atrophy; High risk of AKI in patients undergoing treatment for infected total knee replacement; Tadpole nerve regeneration capacity provides clue to treating spinal cord injury.
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.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips, Roche.
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