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.

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.