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 Inc.
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.