FDAnews Device Daily Bulletin

The House Ways & Means Committee Thursday approved legislation, H.R. 436, to repeal the medical device excise tax — delighting industry.

While judging the Medicines and Healthcare products Regulatory Agency’s (MHRA) response to the PIP silicone breast implant scandal as basically sound, a new review by the UK Department of Health (DOH) finds the agency needs better access to information on devices to preclude similar safety scares in the future.

GOP Representatives could pass a bill repealing the 2.3 percent medical device excise tax by the end of this week, but that doesn’t mean the war is won.

Johnson & Johnson’s Ethicon unit told a federal judge in West Virginia it intends to stop selling four vaginal mesh implants after being sued by more than 600 women who say the products caused internal injuries.

A coalition of healthcare advocates said Congress should force the Obama administration to issue new regulations on medical devices.

Arteriocyte Medical Systems has received U.S. Food and Drug Administration approval for a product associated with its Magellan stem cell harvesting medical device.

Hansen Medical announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Magellan Robotic System, including the catheter and accessories.

Cook Medical said that it has joined a coalition that wants Congress to repeal a legislative measure that would impose excise taxes on its industry.