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The FDA and American Glaucoma Society will hold a workshop to discuss clinical trial design and safety parameters for minimally invasive glaucoma surgery. Read More
An institutional review board at one of Chicago’s major hospitals was handed an FDA warning letter for a slew of violations — many cited previously — in a medical device clinical trial. Read More
A Kentucky hospital has agreed to pay $16.5 million in restitution to resolve allegations it billed Medicare and Medicaid for cardiac implants that were not medically necessary, in violation of the False Claims Act. 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
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