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.

This week, Philips announced a legal settlement on recalled CPAPs and BiPAPs; the FDA released emergency preparation recommendations; ReCor prepared to bring Paradise RDN to the US market; and Abbott released the results of a trial comparing optical coherence tomography (OCT) to angiography for guidance during cardiac surgery.

During a recent webinar, 20-year FDA chief ombudsman Laurie Lenkel explained why her office sees so many device-related cases and what and ombudsman can, and cannot, do for industry.