News Briefs: Panel Supports Cochlear Implant; ReShape Duo Trial Update; Medtronic’s D-fib Lead Software
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
ReShape Submits Dual-Balloon Weight-Loss System PMA
The system, which has been marketed in Europe since 2011, is the first non-surgical weight-loss device to meet its primary endpoints in a U.S., randomized sham-controlled pivotal trial, the firm said.
New Product Briefs: Hearing Device; Volcano’s iFR Modality; St. Jude Pain Device
FDA approved Cochlear Ltd.’s Nucleus Hybrid L24 cochlear implant system, the first implantable device for adults with severe or profound sensorineural hearing loss. Volcano’s instant wave-Free Ratio (iFR) intravascular imaging modality is cleared based on ADVISE II results. More product news.
Industry Sees Harmonization Opportunities In High-level U.S.-EU Trade Talks
Official negotiations between the U.S. and EU on the Transatlantic Trade and Investment Partnership trade agreement began last week. Medical device industry associations representing both regions want the harmonization of U.S. and EU device industry regulations to be part of the agreement.