FDAnews Device Daily Bulletin

A Centers for Medicare & Medicaid Services decision to cover transcatheter aortic valve replacement (TAVR) in patients with inoperable severe symptomatic aortic-valve stenosis could spur uptake of Edwards Lifesciences’ Sapien valve, which was approved late last year. An estimated 45,000 patients have received TAVR worldwide.

The Danish Medicines Agency will inform applicants for device clinical trials within 60 days whether or not their trial plan is approved, according to a recent guidance.

The U.S. Food and Drug Administration issued a recall for specific models of Nemschoff Chairs’ bassinets, model Nos. BSNT/01, BSNT/02, BSNT/03 and BSNT/04.

The doubling of user fees collected from device makers will improve the efficiency of FDA approvals, the agency’s head of medical devices told a congressional panel.

A California federal judge denied NuVasive’s attempts to nullify a patent related to spinal fusion surgery that is part of a portfolio of inventions for which NuVasive owes Medtronic $101 million following a jury’s finding of infringement in September.

HeartWare International shares closed up 2.4 percent after the company won a hearing date before the FDA’s circulatory system devices panel.

London-based Cellnovo commercially launched its cellular-enabled diabetes management system and insulin pump this week in the UK.

Medtronic has announced that it will start a trial with its Symplicity renal denervation system in patients with chronic heart failure.

St. Jude Medical announced it will evaluate the incremental cost-effectiveness of Fractional Flow Reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in Japan, China, India, Korea and Australia.