ProSomnus: ‘We are enabling smart sleep medicine’
By HME News Staff
Updated 9:54 AM CDT, Tue April 14, 2026
SAN FRANCISCO – ProSomnus Sleep Technologies has 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 company says the RPMO2 OSA Device is the first theranostic device for sleep medicine, incorporating both precision oral appliance therapy and multi-night physiologic monitoring in one device. With this new clearance, it says the device is positioned as a cornerstone of a new smart sleep medicine era characterized by connected, patient centric, evidence-driven OSA care. “The FDA’s clearance of the RPMO₂ OSA Device marks a significant milestone for sleep medicine,” stated Len Liptak, CEO of ProSomnus. “By integrating safe, accurate, continuous physiologic measurement into our precision oral appliance platform, we are enabling smart sleep medicine – a connected, data driven model that helps clinicians manage sleep apnea as the personal, individualized and chronic disease it truly is.” Earlier this year, ProSomnus raised $38 million through a strategic investment from Catalio Capital Management to accelerate the expansion of its sleep health platform.
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