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An FDA warning letter last year to Biosense Technologies was a heads-up to mobile app developers, but “the fears of the mobile app industry … that the letter to Biosense represented some new trend of aggressive FDA enforcement” have not come true, one expert says. Read More
A federal court has sentenced a Virginia podiatrist to five months in prison for lying to a grand jury about a medical device Medicare false claims case. Read More
Zimmer Holdings said Thursday that it will acquire orthopedic devicemaker Biomet for $13.35 billion, setting the combined company up as a leader in the $45 billion musculoskeletal market. Read More
BD Biosciences is launching its FACSPresto Near Patient CD4 Counter System in CE mark countries after receiving authorization March 28, the company said Thursday. Read More
Austen BioInnovation Institute of Akron is teaming up with Cleveland’s Nottingham Spirk to hasten biomedical innovation in Ohio, the groups announced Monday. Read More
Florida’s RTI Surgical is launching its Streamline OCT spinal fusion system in the U.S. after receiving 510(k) clearance last month, the company said Monday. Read More
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