Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
News on a Synthes sentencing, Riata recall and other regulatory developments.
You may also be interested in...
Lack Of Device Identifiers On Recalled Cardiac Devices Cost Medicare $1.5Bn, OIG Says
Medicare lost $1.5bn in claims over a 10-year period to cover procedures to fix or replace seven faulty cardiac devices due to the lack of product-specific information on its claims form for malfunctioning defibrillators and pacemakers, says the US HHS Office of Inspector General. Recalls of Medtronic, Boston Scientific and Abbott/St. Jude Medical cardiac rhythm management devices are likely behind most of the cost.
News Briefs: Panel Supports Cochlear Implant; ReShape Duo Trial Update; Medtronic’s D-fib Lead Software
FDA panel supports cochlear implant device. ReShape Medical’s ReShape Duo intragastric balloon meets its primary efficacy endpoints in the REDUCE trial. Medtronic gains FDA approval of defibrillator lead software. More news.
News In Brief
Justice investigates St. Jude’s Riata recall. Boston Scientific mesh devices under investigation. More news briefs.