ProSomnus Severe Indication 510(k) Submission Accepted for Review by the FDA
ProSomnus, Inc. (OSA)
Company Research
Source: GlobeNewswire
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 represents a significant step towards expanding access to care for the millions of patients with Obstructive Sleep Apnea who prefer a safe, effective and convenient treatment alternative to CPAP or invasive procedures,” commented Len Liptak, ProSomnus Chief Executive Officer. “We look forward to working closely with the FDA throughout this review process as we look to expand the labeling for our precision Oral Appliance Therapy device.” The Company’s premarket notification 510(k) s
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OSA
News
- ProSomnus Reports Record Fourth Quarter and Fiscal Year 2023 Financial ResultsGlobeNewswire
- ProSomnus Reschedules Fourth Quarter and Fiscal Year 2023 Investor and Business Update CallGlobeNewswire
- ProSomnus Reports Successful Pilot Study Validation of Next Generation Remote Patient Monitoring Device for Obstructive Sleep ApneaGlobeNewswire
- ProSomnus Announces Fourth Quarter and Fiscal Year 2023 Investor and Business Update Call and Participation at the 36th Annual ROTH Conference in March 2024GlobeNewswire
OSA
Earnings
- 11/9/23 - Miss
OSA
Sec Filings
- 4/30/24 - Form 8-K
- 4/18/24 - Form 8-K
- 3/27/24 - Form 10-K
- OSA's page on the SEC website