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The FDA has issued draft guidance standardizing the way companies report computational modeling and simulation studies, paving the way for more computer modeling in medical device trials. Read More
American Aesthetics Medical Supply, a Dallas-based maker of microdermabrasion systems and crystals, lacks appropriate procedures for its suppliers and receipt of incoming ingredients, according to an FDA warning letter. Read More
The FDA does not review new clinical data in considering most cardiac implantable electronic devices, according to a study in last week’s Journal of the American Medical Association — a fact the authors say may have contributed to several high-profile recalls. Read More
Business is on the upswing for St. Jude Medical’s once-beleaguered cardiac rhythm management division, which experienced strong growth in the 2013 fourth quarter. Read More
Irish devicemaker Covidien said Tuesday it is halting development on the OneShot renal denervation system, marking yet another blow to a technology once seen as the future of hypertension treatment. Read More
Mega Electronics, maker of the FemiScan Home Trainer incontinence device and the ME6000 biomonitor device, received an FDA warning letter for incoming inspection shortfalls and other quality issues. Read More
Devicemakers using material from animals that could carry transmissible spongiform encephalopathies should document the absence of TSE disease and standard vaccinations, such as live modified viruses, that the animal received, an updated FDA guidance says. Read More
The U.S. Supreme Court Wednesday unanimously ruled that patent holders must prove infringement, even in cases where a licensee initiated the litigation. Read More
Vietnam’s Ministry of Health has issued a decree specifying requirements for the manufacture, sale, services, information and advertising of medical devices. Read More
Even as more and more healthcare is moving into the home, manufacturers and other stakeholders remain ill-prepared to serve that patient population. Read More