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 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.
About the ProSomnus RPMO2 OSA Device
The ProSomnus RPMO2 OSA Device is the first theragnostic device for sleep medicine, featuring a wholly embedded oximeter for safe, accurate and economical treatment and multi-night monitoring of OSA. The oximeter is encapsulated in an overlay of the maxillary dentition and uses the mucosa of the buccal vestibule behind the upper lip as the reflective tissue. Data are transmitted to a secure provider portal via patient smartphone app.
Validated Accuracy and Safety
The RPMO2 OSA Device's FDA clearance is supported by a rigorous, gold standard validation study conducted at the University of Calgary and published by Snow et al. (2025). The study evaluated the accuracy of the intraoral buccal mucosal oximeter against arterial oxyhemoglobin saturation measured using CO oximetry, the clinical gold standard for oxygen saturation measurement.
Comprehensive Controlled Desaturation Study
The study enrolled 12 healthy adults, consistent with ISO 80601 2 61 requirements, and included participants with a spectrum of skin pigmentation.
Participants underwent six precisely controlled hypoxic plateaus, spanning ~97% to ~72% SaO2. Analysis of accuracy was performed on 325 SaO2/SpO2 data pairs and 346 pulse rate/ECG data pairs.
Oxygen Saturation Accuracy
The RPMO2 OSA Device demonstrated strong clinical accuracy across the full range of 70-100% SaO2:
- Accuracy Root Mean Square (ARMS) for SpO2: 2.94%
- Correlation between SpO2 and SaO2: r = 0.95
- Bland-Altman: mean bias of 0.72, upper and lower 95% limits of agreement of 6.31 and -4.86, respectively
- Consistent accuracy across entire range of SaO2 tested
Importantly, the study reported no systematic bias across skin pigmentation groups. The buccal mucosa, which is thought to contain less melanin than the epidermis, may reduce the overestimation of oxygen saturation seen in conventional fingertip devices that measure through melanin-rich tissue.
Pulse Rate Accuracy
The RPMO2 OSA Device also demonstrated excellent pulse rate measurement performance:
- ARMS: 2.08 beats per minute
- Correlation between pulse rate and ECG: r = 0.99
- Bland-Altman: mean bias of 0.30, upper and lower 95% limits of agreement of 4.34 and -3.73, respectively
Mitigation of Known Oximetry Confounders
The innovative intraoral design of the RPMO2 OSA Device addresses several long recognized limitations of conventional pulse oximeters:
- Motion artifact reduction: Stable placement high in the buccal vestibule minimizes motion-induced noise.
- High perfusion site: The buccal mucosa is richly vascularized, supporting high quality photoplethysmography.
- Thermal stability: The temperature-stable intraoral environment avoids temperature dependent perfusion variability.
- Intrinsic light shielding: The vestibular location protects the sensor from ambient light interference.
- Low melanin interference: Measurement through mucosa may reduce racial bias inherent in skin based oximetry.
Collectively, these attributes support the RPMO2 OSA Device's suitability for accurate, nightly physiologic monitoring in real world settings.
Enabling Smart Sleep Medicine
The FDA clearance of the RPMO2 OSA Device unlocks Smart Sleep Medicine, ProSomnus's next generation, connected care model for managing OSA as a chronic disease. The RPMO2 OSA Device enables:
- Longitudinal physiologic monitoring across nights and treatment stages
- Evidence based, connected care workflows including remote physiologic monitoring (RPM)
- Real world insights enabling personalization of precision oral appliance therapy
- Improved patient engagement and outcomes through continuous, comfortable monitoring
About ProSomnus Sleep Technologies
ProSomnus is the pioneer and global leader in Smart Sleep Medicine, providing a technology-enabled, non-CPAP alternative for the treatment of Obstructive Sleep Apnea (OSA). A serious medical disease affecting over 1 billion people worldwide, OSA is linked to life-threatening comorbidities including heart failure, stroke, and type 2 diabetes.
By integrating precision-engineered intraoral medical devices with advanced remote patient monitoring (RPM) and data-driven diagnostics, ProSomnus is redefining the standard of care. Our platform is designed to provide continuous, nightly clinical insights that ensure superior adherence and validated patient outcomes. Non-invasive and patient-preferred, ProSomnus devices have demonstrated exceptional efficacy and safety across a rigorous and growing body of clinical evidence. ProSomnus precision devices are FDA-cleared, patented, and covered by commercial medical insurance, Medicare, and TRICARE, representing over 200 million covered lives globally. To learn more about the future of sleep health, visit www.ProSomnus.com.
Media Contact
Heather Whalen
HWhalen@ProSomnus.com
Photos accompanying this announcement are available at
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