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Members of the Council of Europe are at odds over whether to allow reprocessing of single-use devices, and the disagreement could upend efforts to pass device reform legislation before EU elections in May. Read More
Medtronic is enrolling patients in the VICTORY AF trial to evaluate the safety of its investigational Phased RF system for atrial fibrillation. Read More
The FDA has issued final orders downclassifying external counterpulsating (ECP) devices, intra-aortic balloon and control system (IABP) devices and temporary mandibular condyle prostheses for certain indications. Read More
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