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German devicemaker I.E.M. was hit with a warning letter after FDA investigators found shortcomings with medical device report (MDR) procedures and an array of quality “nonconformities” during a recent inspection of the company’s Stolberg, Germany, facility.
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Executives in the medical device manufacturing industry predict that a new excise tax and the burden of its related compliance costs will hurt their companies’ bottom lines, according to a survey conducted by KPMG, an audit, tax and advisory firm.
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Researchers from Princeton and Purdue universities have developed a prototype firewall, called MedMon, which could prevent hackers from manipulating wireless medical devices.
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St. Jude Medical announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare and the launch of the Trifecta aortic stented, pericardial tissue valve.
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Qiagen today announced its real-time PCR instrument Rotor-Gene Q MDx and the artus Infl A/B RG RT-PCR kit for Influenza A/B has received 510(k) clearance from the FDA.
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A federal appeals court said that an Arizona man cannot sue a medical device manufacturer under state law for injuries from a pain pump that he said left him paraplegic.
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