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The FDA is classifying pancreatic drainage stent and delivery systems as Class II with special controls, but will still require premarket notification before distribution. Read More
Stryker has publicly denied any immediate plans to acquire British devicemaker Smith & Nephew, but left open the door for a future takeover bid. Read More
The Obama administration has radically reinterpreted the doctrine of preemption in pressing the Supreme Court not to hear a case involving a Medtronic pain pump, attorneys familiar with the U.S. solicitor general filing say. Read More
The Centers for Medicare & Medicaid Services has set June 1 as the start date for Phase 2 of Open Payments data submissions under the Physician Payment Sunshine Act. Read More
Sen. Patrick Leahey (D-Vt.) effectively killed any chance at patent reform legislation by removing H.R. 1720 from the agenda of the Senate Finance Committee, which he chairs. Read More
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More
All devicemakers holding CE certificates for Class IIa medical devices and higher should be prepared for unannounced quality system visits by notified body inspectors. Read More
Massachusetts-based Fresenius Medical Care North America has issued two voluntary recalls of a concentrate used in dialysis machines over fears of bacterial contamination, the FDA said. Read More