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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
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supports the use of Activa Healthcare’s Debrisoft pad for wound debridement in community clinics or at home, a draft guidance says.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
If sequestration cuts continue into the 2014 fiscal year, CDRH will not be able to hire the review staff the agency promised to hire under MDUFA III, Director Jeffrey Shuren told Congress Friday. Read More
Seattle-based Atossa Genetics has initiated a Class I recall of all lots of its Mammary Aspiration Specimen Cytology Test (MASCT) and the accompanying patient sample kit, along with the ForeCYTE Breast Health Test Kit, manufactured between Jan. 9 and Sept. 13, 2013. Read More
A group of patient advocacy organizations is urging Congress to pull back on proposed cuts in Medicare coverage for medical imaging, saying further reductions will seriously impede access to life-saving screening and radiation therapy services. Read More
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