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The software uses an AI software platform developed by Anumana’s parent company, nference, which contains more than 6 million de-identified patient records. Read More
Boston Scientific will expand its stent manufacturing pipeline by acquiring Synergy Innovation’s majority stock holdings in M.I. Tech, a Korean company that created a family of specialty endoscopic and urologic stents that Boston Scientific has distributed in Japan since 2015. Read More
The FDA issued Photonic Health an eight-observation Form 483 after an inspection of the company’s Ocala, Fla., facility in March found the firm had failed to address deficiencies observed in a previous inspection. Read More
The Medicines Patent Pool (MPP) has inked a patent-sharing agreement with South African pharmaceutical company Biotech Africa to accelerate the manufacturing and sale of a COVID-19 antibody test. Read More
Miami, Fla.-based DermaSensor said two studies of its handheld skin cancer detection device — which could become the first FDA-cleared device of its kind for use by primary care physicians — have demonstrated the device’s efficacy. Read More
Novarad’s 3D augmented reality surgical navigation system VisAR has received 510(k) clearance from the FDA for precision-guided spine surgery. Read More
The FDA’s Center for Device and Radiological Health (CDRH) has released final guidance on what technical performance assessment and user information should be included in a premarket submission for radiological devices with quantitative imaging functions. Read More
Cyberattacks have become a routine occurrence, prompting radical changes in the way device manufacturers think about the problem, all the way back to the design stage, according to a panel discussion Tuesday at the Food and Drug Law Institute’s annual conference. Read More