FDA reviews adverse events, durability of Inspire Medical's sleep apnea implant

Inspire Medical's Inspire II Upper Airway Stimulator heads to the FDA tomorrow, when an expert panel will consider admitting the device to the U.S. market.

Minnesota-based Inspire Medical Systems has a date with the FDA tomorrow, when the agency's expert Anesthesiology & Respiratory Therapy Devices Panel will review data and make a recommendation on the Inspire II Upper Airway Stimulator.
Food & Drug Administration (FDA), Inspire Medical Systems Inc.News Well, Regulatory/Clearance, Food & Drug Administration (FDA), Minnesota, Neuromodulation/Neurostimulation, Pre-Market Approval (PMA), Sleep Monitoring/Sleep Apnearead more

Source: Mass Device - February 19, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news