An ongoing recall of Edwards Lifesciences’ Sapien 3 Ultra transcatheter heart valve system has been elevated to Class I, indicating the US FDA’s highest risk level.

The US FDA has approved Zimmer Biomet’s Tether device, which is the first device of its type cleared to treat children with a form of spinal curvature. It's also the first pediatric spinal device to net Humanitarian Device Exemption approval from the agency in 15 years, the company says.

Danish device-maker Ambu has agreed to pay $3.3m to resolve allegations of False Claims Act violations. The company is said to have made medical product in Malaysia and China for sale to the Departments of Defense and Veterans Affairs, which is forbidden under the Trade Agreements Act.

US FDA's long-delayed final rule on postmarketing safety reporting will mostly go into effect next July, though manufacturers who file reports via the Vaccine Adverse Event Reporting System have a little extra time, with their compliance date set for 31 January 2021.

Most combination product applicants will need to comply with an FDA final rule on postmarketing safety reporting as of 31 July 2020.

Johnson & Johnson subsidiary Mentor Worldwide won’t have to face lawsuits filed by women who say they were injured by the company’s MemoryGel silicone breast implants. A California federal court ruled that FDA preemption blocked the suits.