ProSomnus Sleep Technologies has received the US Food and Drug Administration (FDA) Class II 510(k) clearance for its RPMO₂ OSA device.
The device is said to be the first to combine both precision oral appliance therapy and multi-night physiological monitoring for sleep medicine, representing a new approach in connected, patient-centred obstructive sleep apnoea (OSA) care.
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It features a fully embedded oximeter positioned over the maxillary dentition and uses the buccal vestibule mucosa behind the upper lip for measurements.
It transmits data securely via a patient smartphone app to a provider portal for monitoring and care.
The FDA clearance follows a gold standard validation study at the University of Calgary, published by Snow et al. in 2025, comparing the intraoral oximeter’s accuracy to clinical gold-standard carbon monoxide (CO) oximetry.
In the study involving 12 adults, subjects experienced six controlled hypoxic plateaus; accuracy analysis included 325 arterial oxygen saturation (SaO₂) / peripheral oxygen saturation (SpO₂) pairs and 346 pulse/ECG pairs.
ProSomnus stated that RPMO₂ enables nightly monitoring, remote physiologic management, and personalisation of OSA therapy, supporting ongoing patient engagement and outcomes.
ProSomnus CEO Len Liptak said: “The FDA’s clearance of the RPMO₂ OSA Device marks a significant milestone for sleep medicine. 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, individualised and chronic disease it truly is.”
ProSomnus scientific and medical affairs director Erin Mosca said: “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.”
Earlier this year, the company secured $38m in funding to support the global expansion of its oral appliance therapy (OAT) devices for OSA.
