ProSomnus Sleep Technologies 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 Len Liptak, Chief Executive Officer 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.”
“The RPMO₂ OSA Device represents years of innovation in engineering, human centric design, and rigorous scientific validation. We set out to create a miniature, highly accurate, comfortable oximeter capable of real-world performance. FDA clearance confirms that we achieved this goal and opens the door to continuous insight into patient physiology,” commented Sung Kim, ProSomnus Chief Technology Officer.
“Dentists play a vital role in screening and treating Obstructive Sleep Apnea (OSA). The ProSomnus RPMO₂ OSA Device gives dental providers a powerful new tool—real world data that shows how patients are responding night after night. This enables proactive, personalized care, enhanced communication with patients and physicians, and improved outcomes, commented Mark Murphy, DDS, D.ABDSM, FAASM, ProSomnus Dental Sleep Medicine Director.
“The ProSomnus RPMO2 OSA Device stands to elevate the practice of sleep medicine by simplifying device titration by allowing for the use of robust, objective SpO2 data to guide device titration where previously subjective patient feedback has been used,” noted Erin Mosca, PhD, ProSomnus Director of Scientific and Medical Affairs.
“Oral Appliance Therapy is integral to the treatment of Obstructive Sleep Apnea, and oximetry is integral to its diagnosis and follow up. The ProSomnus RPMO2 OSA Device now offers clinicians the ability to continuously and easily monitor treatment without employing additional diagnostic tools. The implications for managing such a large number of patients are self-evident,” commented Adrian Williams, MD, PhD.
“For the first time, clinicians can pair precision oral appliance therapy with continuous, longitudinal physiologic monitoring. This supports data driven treatment adjustments, mitigates limitations of single night testing, and positions sleep apnea care alongside modern chronic disease management paradigms,” noted Edward Sall, MD, DDS, ProSomnus Medical Director.
“Oral appliances play an increasing role in the therapeutic armamentarium for sleep apnea. The RPMO2 OSA Device provides the potential to more rapidly titrate patients on oral appliance therapy to an effective setting. The ability to monitor oximetry and adherence over multiple nights should allow for more accurate assessments of treatment efficaciousness. In addition, the application of oximetry to the buccal mucosa bypasses concerns of oximetry accuracy on pigmented skin and so should help reduce existing racial disparities in sleep apnea care. I am excited about the potential that RPMO2 has to improve the care of my patients with sleep apnea,” stated Sanjay V. Patel, MD.
“Efficacy of and adherence to interventions in chronic illness are key pillars of disease control and improved outcomes, and OSA is no exception. Hypoxic burden is the underpinning of many OSA-related diseases. Continuous SpO₂ monitoring with ProSomnus RPMO2 uniquely provide a pathophysiologically derived efficacy measure. RPMO2 goes one step forward and provides a measure of adherence that was not available previously. The above makes RPMO2 an important paradigm changing technology in a major intervention for management of OSA,” commented Amir Sharafkhaneh, MD, PhD.
“From preliminary research we have been doing in our clinics, we have found the ProSomnus RPMO2 OSA Device to be very reliable when comparing the physiologic data to that proffered by robust sleep studies, giving us confidence when discussing this new technology with both patients and our referral sources. This not only allows us to monitor treatment success nightly for titration purposes, but we see better compliance as patients love to see how their previous day’s activities influenced the quality of their sleep,” stated Kent Smith, D.ABDSM, FAASM.
“Access to nightly physiologic data with the ProSomnus RPMO2 OSA Device has fundamentally changed how we manage OAT for OSA patients. Instead of relying on snapshot testing or symptoms alone, we can track trends over time, make more precise titration decisions, reduce unnecessary testing, and identify issues earlier—ultimately improving outcomes, patient adherence, and confidence in both the therapy and our clinical recommendations,” commented Stacey Layman, DDS, D.ABDSM, D.ABSA.
“The ProSomnus RPMO2 OSA Device has transformed how I evaluate Oral Appliance Therapy. Multi-night, medically verified data reveals night-to-night variability that one- or two-night titration studies simply miss, enabling truly patient-specific, data-driven treatment decisions. Physician colleagues are consistently impressed by the rigor of the validation, the quality of the data, and the high patient adherence—and prefer their patients treated with therapy supported by this level of objective monitoring,” noted Michael J. Murray, DDS.
