ProSomnus announces FDA acceptance of 510(k) submission for EVO device

ProSomnus announced that the United States Food and Drug Administration 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 Company’s premarket notification 510(k) submission included a robust clinical data dossier demonstrating the safety and efficacy of its ProSomnus EVO precision medical device relative to the performance goals indicated in pre-submission meetings and reference devices. The clinical data submitted by the Company in support of its 510(k) submission included data on 92 patients with severe OSA from two prospective clinical studies.