We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
NeuroPace plans to launch its RNS Stimulator in the U.S. as soon as possible, following last week’s FDA approval of the novel anti-seizure device. Read More
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
Human Design Medical Thursday launched its “lighter, smaller, quieter” Z1 continuous positive airway pressure device for sleep apnea patients looking for more mobile nighttime breathing support. 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
French medical devicemaker Carmat hopes to wrap up clinical studies of its artificial heart in Europe in time for a 2015 launch date — with eyes on U.S. market entry sometime thereafter. Read More
Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last week by the Asian Harmonization Working Party. Read More