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FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More
The FDA has granted 510(k) clearance for next-generation software that allows collection of plasma alone on Fenwal’s Alyx blood collection system. Read More
The Sorin Group has sent a Dear Doctor letter to physicians after Hong Kong’s Department of Health received eight reports of faulty elective replacement indicators used to program the settings on three of the company’s pacemakers. Read More
The FDA Wednesday granted TauTona 510(k) clearance for its battery-powered, single use TauTona Tissue Injector (TTI) fat-grafting device for use in aesthetic and reconstructive surgeries. Read More
An effort to foster better communication between the FDA’s drug and device centers is starting to pay off, with fewer requests for duplicate data on companion diagnostic submissions. Read More
San Francisco-based AliveCor Monday announced the U.S. launch of its AliveInsights app, which allows patients to receive feedback on electrocardiogram data gleaned from the company’s heart rate and rhythm monitor. Read More
Wright Medical Technology has completed its acquisition of Biotech International, a Salon-de-Provence, France, dental and orthopedic implant maker, in a deal worth $75 million. As part of the transaction, Biotech spun off its dental operations. Read More
The China Food and Drug Administration plans to step up its tracking of medical device adverse events in hospitals, and is asking high-risk and Class III devicemakers to refer to a 2011 guideline on electronic monitoring to facilitate submission of incident reports. Read More
The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet specification for mechanical testing. Read More
The UK’s National Institute for Health and Care Excellence supports the use of Activa Healthcare’s Debrisoft pad for wound debridement in community clinics or at home, a draft guidance says. Read More
Medical devicemakers should be aware that they have become “lower-hanging fruit” for FDA enforcement of off-label promotion rules, and so have online product communications, two experts say. Read More