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Heart patients in the U.S. would no longer have access to Medtronic’s CoreValve transcatheter valve if a preliminary injunction handed down in federal court takes effect. Read More
Varian Medical Systems will pay the University of Pittsburgh $35 million to settle claims that its Real-Time Position Management device infringed on a patent held by the university. Read More
Covidien is recalling certain lots of its Pipeline embolization devices and Alligator retrieval devices due to a defect in the coating applied to the delivery wire. Read More
Devicemakers saw an increase in 2013 in the number of FDA 483s that cite inadequate supplier controls; the finding is now one of the top five most common 483 findings for devicemakers. Read More
The U.S. military’s Committee on Tactical Combat Casualty Care has approved the use of Medtrade’s Celox Gauze to control bleeding from combat injuries. Read More
The U.S. Food and Drug Administration does not mandate the use of specific international standards, allowing manufacturers to explore science-based alternatives. Read More
The U.S. Food and Drug Administration may withdraw a humanitarian device exemption if it subsequently approves a premarket approval application or clears a 510(k) for a humanitarian-use device or a comparable device with the same indication, draft Q&A guidance explains. Read More