The FDA has granted 510(k) clearance for Kinetic Concepts’ V.A.C. Via negative-pressure wound therapy device for patients whose wounds drain 80 mL or less of exudate per day. Read More

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

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 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

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

Boston Scientific has received CE Mark approval for its Vercise deep brain stimulation system in patients with dystonia. 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