Fresenius Medical Care has agreed to pay $231m to resolve reports of overseas bribery. The US Department of Justice says the dialysis giant paid bribes to health and government officials in Angola and Saudi Arabia, and failed to keep accurate financial records in Angola, Saudi Arabia, Morocco, Spain, Turkey, and several countries in West Africa.

This week, studies supported Nevro’s spinal cord stimulation therapy and a VRx system that helps reduce pain; the American Medical Association found inconsistent insurance coverage of digital therapeutics; and Geneticure announced a cheek-swab test to identify which patients are most likely to benefit from renal denervation.

Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.