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ProSomnus Severe Indication 510(k) Submission Accepted for Review by the FDA
OSAProSomnus(OSA) Newsfilter·2024-01-30 13:00

PLEASANTON, Calif., Jan. 30, 2024 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (NASDAQ:OSA) (the "Company"), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, announced today that the United States Food and Drug Administration (the "FDA") has accepted, and is in the process of reviewing, the Company's premarket notification for its ProSomnus® EVO® precision medical device for the treatment of patients with severe obstructive sleep apnea. "The acceptance of our 510(k) submission for substantive review repr ...