News Briefs: Panel OKs Sleep Apnea Stimulator; Two Stryker Buys; TAVR Updates
This article was originally published in The Gray Sheet
Executive Summary
FDA panel unanimously endorses Inspire upper airway stimulator. Stryker buys Berchtold and Pivot. First randomized U.S. study of embolic protection during transcatheter aortic valve replacement approved. More news.
You may also be interested in...
Capitol Hill Briefs: Device Tax Repeal; Clinical Trials; DME Bidding
Legislation introduced in the new Republican-controlled Senate include device tax repeal, a measure that would allow Medicaid recipients to enroll in clinical trials and a bill, introduced in parallel in the House, aimed at stopping non-binding bids for supplying durable medical equipment, prosthetics, orthotics and supplies.
Claret Targets TAVR Stroke Risk With Sentinel Embolic Filter Device
The company launched the SENTINEL trial in the U.S., the first prospective, randomized, controlled, blinded trial in the U.S. of a cerebral protection device for transcatheter aortic valve replacement.
News Briefs: FDA Approves AF Catheter; Tax Reform Proposal; Renal Denervation
FDA approved a PMA supplement for Biosense Webster’s Thermocool SmartTouch, the first FDA-approved ablation catheter that can measure contact force in real time. J&J earns a CE mark for its Renlane renal denervation system. More news briefs.