ProSomnus announced that it received FDA 510(k) clearance for its RPMO₂ obstructive sleep apnea (OSA) therapy device.
San Francisco–based ProSomnus says its clearance marks the first for a theragnostic device for sleep medicine. RPMO₂ incorporates both precision oral appliance therapy and multi-night physiologic monitoring in a single device.
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The RPMO₂ device capabilities include measuring oxygen saturation (SpO₂) and pulse rate. ProSomnus says its device delivers connected, patient-centric, evidence-driven OSA care in the new “Smart Sleep Medicine” era. The company brought in $38 million earlier this year to support this technology.
According to ProSomnus, the device incorporates a fully embedded oximeter for safe, accurate multi-night OSA monitoring. Encapsulated in an overlay of the maxillary dentition, the oximeter uses the mucosa of the buccal vestibule behind the upper lip as reflective tissue. Data is transmitted to a secure provider portal via a patient smartphone app.
The device utilizes longitudinal physiologic monitoring across nights and treatment stages, with real-world insights enabling personalized therapy. ProSomnus also reports improved patient engagement and outcomes through its continuous, comfortable monitoring.
RPMO₂ offers another alternative to the leading continuous positive airway pressure (CPAP) machines used to treat OSA. Resmed (and, at one point, Philips) are two big names in the CPAP space. Other alternatives, like neurostimulation, comes from companies like Inspire Medical, Nyxoah and most recently LivaNova.
Len Liptak, CEO of ProSomnus, 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, individualized and chronic disease it truly is.”
Sung Kim, ProSomnus chief technology officer, said:
“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.”
