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GI Dynamics’ announced final data from a multisite clinical study of its experimental EndoBarrier system, saying it met its endpoints in glycemic control efficacy and serious adverse events (SAE). Data also show clinically significant weight loss, the Boston-based company said. 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
In observance of the Juneteenth holiday, FDAnews Device Daily Bulletin Premium will not be published Monday, June 20. The next issue will be published Tuesday, June 21. 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