New Product Briefs: Hearing Device; Volcano’s iFR Modality; St. Jude Pain Device
This article was originally published in The Gray Sheet
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.
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FDA posted its official listing of March PMAs this week, including original PMA approvals for devices from Abbott Laboratories, Cochlear Ltd. and Roche Diagnostics. Also, average time-to-decision data for PMA supplements.
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.
The system, which developers hope to launch in the U.S. in 2015 following completion of a 510(k) submission to FDA, will cost about $50 million for a two-room configuration, and the gantry will weigh 15 tons, well under the typical 110-220-ton weight of most systems, according to ProNova.