FDAnews Device Daily Bulletin

Lax process and quality control of supplied components helped land Irving, Texas-based Epimed International an FDA warning letter.

As widely anticipated in the wake of the PIP breast implant and metal-on-metal hip scandals, the European Commission is proposing that high-risk medical devices undergo more rigorous premarket scrutiny, but not on the level required by the U.S. Food and Drug Administration (FDA).

As more medical-related mobile applications become available to consumers, the Food and Drug Administration is making sure the most high-risk apps are safe to use.

The U.S. 6th Circuit Court of Appeals dismissed an $82.6 million judgment against Fresenius Medical Care Holdings, finding that the company did not violate Medicare’s rules concerning dialysis claims.

BD Medical announced that the BD Vystra Disposable Pen will be showcased at the 2012 Parenteral Drug Association Meeting in Las Vegas.

Cardinal Health announced the expansion of its Jackson-Pratt Surgical Wound Drain category, which now includes a more comprehensive selection of high-quality active and passive surgical wound drain systems.

Boston Scientific has enrolled the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus Valve System in up to 120 patients with severe aortic valve disease.

Canadian medical-device maker Monteris Medical Inc. has opened an office in Plymouth as it ramps up marketing of its technology for treating brain tumors.