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Postmarket studies for devices known to affect men and women differently should be engineered to enroll more female patients, the FDA says following publication of a review of postmarket studies by CDRH scientists. Read More
The Court of Appeals for the Federal Circuit should dismiss an appeal from Consumer Watchdog because the group lacks standing to challenge a stem cell patent held by Wisconsin Alumni Research Foundation, according to an amicus brief filed by the U.S. Department of Justice. Read More
Legislation establishing a device regulatory framework in Malaysia took effect just six months ago, and the Medical Device Authority wants to hear from stakeholders on how implementation and the transition to establishment licensing and device registration is going. 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 FDA granted AtheroMed’s Phoenix Atherectomy System 510(k) clearance to treat vessels below the knee in patients with peripheral artery disease. 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