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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
ITGI Medical and Vascular Solutions plan to begin enrolling patients in a humanitarian device exemption trial of ITGI’s Aneugraft Dx coronary stent during the first quarter of next year. Read More
Australia’s medtech field is growing rapidly, grossing roughly US $93 billion in 2012 and claiming a total of 41,292 devices on the Australian Register of Therapeutic Goods, a new industry report shows. 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supports the use of Activa Healthcare’s Debrisoft pad for wound debridement in community clinics or at home, a draft guidance says.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
Johnson & Johnson is expected to pay more than $4 billion to settle lawsuits against the company over injuries attributed to Articular Surface Replacement (ASR) metal-on-metal hips made by its DePuy business unit, multiple news sources report. Read More
Physicians responding to a recent FDA survey reported good results with Intuitive Surgical’s da Vinci surgical system, but also highlighted a range of failures involving the robotic device. 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