FDA Clears ProSomnus’s EVO [PH] Sleep and Snore Device
ProSomnus has received 510(k) clearance from the FDA for its ProSomnus EVO [PH] precision Herbst appliance for patients with obstructive sleep apnea, a disorder that causes sleepers to temporarily stop breathing.
The latest addition to the company’s EVO sleep apnea products, the Herbst-style appliance uses hinges to reposition and stabilize the jaw during sleep, increasing pharyngeal space and reducing the risk of upper airway collapse.
Each device is personalized and digitally manufactured based on the patient’s unique anatomy and the healthcare provider’s treatment plan.
The new device offers an alternative to continuous positive airway pressure (CPAP) machines, surgery and legacy oral appliances, the company said.