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The U.S. Supreme Court has denied an appeal from a radiologist who sought to invalidate a patent on Johnson & Johnson’s drug-eluting Cypher stents. Read More
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
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