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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
A spate of recent federal false claims cases involving the use of durable medical equipment underscore the government’s continued scrutiny of the segment, an attorney says. 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
The global bone grafts and substitutes market is expected to grow steadily, from nearly $2.1 billion last year to about $2.7 billion by 2020, according to consulting firm GlobalData. Read More
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