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The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, used with its Renasys line of negative pressure wound treatment devices. Read More
A group of Senate Democrats is pressing the Office of Management and Budget to release long-promised draft guidance on laboratory-developed diagnostic tests. Read More
Over the next four years, the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
The Department of Commerce plans to submit a list of all known conflict mineral processing facilities to Congress by Sept. 1, according to a new report from the Government Accountability Office. Read More
Venture capitalists interested in the mobile health sector may want to take a closer look at clinical app investments, a recent report by Boston-based Lux Research suggests. Read More
The government should provide grants for public-private partnerships working to advance new medical technologies, William Murray, president and CEO of the Medical Device Industry Consortium, told lawmakers Wednesday. Read More
Australia’s Therapeutic Goods Administration logged a total of 3,309 adverse event reports in 2013, the overwhelming majority from manufacturers, according to a new report. Read More
The U.S., Canada, Australia and Brazil were supposed to begin shared audits this month under the International Medical Device Regulators Forum’s medical device single audit program. Read More
Coronary devicemaker HeartWare International has received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility. Read More