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.

Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.

The US FDA has finalized a guidance document on the Voluntary Improvement Program, which aims to help manufacturers continuously improve quality and compliance.

The US Government Accountability Office spoke to 11 stakeholder groups about potential trouble spots in FDA and FTC supervision of consumer ads for medical devices. 

Data from the US Food and Drug Administration shows that the agency has granted 853 breakthrough device applications since 2015, out of 1,909 applications. The acceptance rate has varied from 33% in 2016 to 72% in 2017, with acceptance rates in recent years hovering around the 40% mark.