Updated February 24, 2014, with details from Inspire Medical.
An expert panel of FDA advisors voted today to recommend approval for Inspire Medical’s sleep apnea implant, the Inspire II Upper Airway Stimulator, the company confirmed.
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.
Inspire Medical Systems is getting the FDA treatment, landing a date next month with the Anesthesiology & Respiratory Therapy Devices panel to undergo review of the company’s implanted Inspire II Upper Airway Stimulator for treatment of obstructive sleep apnea.
Medtronic Inc. (NYSE:MDT) spinout Inspire Medical Systems Inc. received the go-ahead from regulators to sell its obstructive sleep apnea device in Europe and test it for the U.S. market.
CE Mark approval in hand, the Maple Grove, Minn.-based device developer expects to mount a market development push for its Inspire upper airway stimulation therapy in Europe near year-end 2011.