ProSomnus® Receives FDA Class II Clearance for RPMO2 OSA Device
Lakeshore Acquisition I Corp. - Ordinary Shares (LAAA)
Company Research
Source: GlobeNewswire
SAN FRANCISCO, April 13, 2026 (GLOBE NEWSWIRE) -- ProSomnus Sleep Technologies (“the Company”), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy® and pioneer in Smart Sleep Medicine™, today announced that the U.S. Food and Drug Administration (FDA) has granted Class II 510(k) clearance for its RPMO2 OSA Device under the product codes DQA, LQZ, LRK, PLC, and OUG (FDA K252765). The RPMO2 OSA Device is the first theragnostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device. This clearance affirms that the ProSomnus RPMO2 OSA Device meets the FDA’s standards for safety and effectiveness in measuring oxygen saturation (SpO2) and pulse rate, positioning the device as a cornerstone of a new Smart Sleep Medicine era characterized by connected, patient centric, evidence-driven OSA care. Commentary “The FDA’s clearance of the RPMO2 OSA Device marks a significant milestone for sleep medicine,” stated
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