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Racer Technology, a Singapore maker of cochlear implant accessories, expressed confusion about the term “device history record” during a recent FDA inspection, drawing a warning letter from the agency. Read More
The promising new hypertension treatment known as renal denervation is safe in the short to medium term, but more safety information is needed before conclusions can be drawn about its long-term benefits versus standard care in treating treatment-resistant hypertension, according to a rapid assessment by the European Network for Health Technology Assessment. Read More
Devicemakers faced myriad challenges in 2013, as new rules and practices went into effect under the Affordable Care Act, FDASIA and the Physician Payment Sunshine Act. FDA offered guidance on a number of issues, including IVDs for research use only, medical device development tools and priority reviews. Globally, the year saw a steady push toward enactment of new device regulations in the EU, clampdowns on industry bribes in China and Brazil, and strict clinical trial compensation rules in India, to name just a few key developments. Here are 10 issues that kept industry buzzing this year. Use this list to review your regulatory program and prepare a successful business strategy for 2014.Read More
Invacare says it has made “significant progress” on its FDA consent decree, but must do some additional work on its complaint system before an independent auditor provides final certification to the agency. Read More
New York City startup Kinsa Health has won 510(k) clearance for its smartphone-connected thermometer for adults and children, the company announced Thursday. Read More
CME America failed to investigate the adequacy of its device labeling following three MedWatch reports on administration sets that related to the way a customer was using the device, according to a Form 483 issued to the Golden, Colo., devicemaker. Read More