Obstructive sleep apnea (OSA) treatment devices manufacturer ProSomnus has obtained 510(k) clearance for its EVO [PH] Sleep and Snore Device from the US Food and Drug Administration (FDA).
The device has been engineered to provide a new OSA treatment option for Medicare beneficiaries and their healthcare providers.
It is designed as an easy-to-use, comfortable, non-invasive and effective alternative to continuous positive airway pressure (CPAP) machines, surgery and legacy oral devices.
The ProSomnus EVO [PH] Sleep and Snore Device has unique comfort bumps around key components and is said to be nearly 13% smaller than predicate devices.
It includes unique advancement markings as well as visual indicators to allow users to communicate with their healthcare providers during treatment.
The company personalises and digitally manufactures the device based on each patient’s unique anatomy and treatment plan.
ProSomnus’ EVO [PH] expands the company’s suite of FDA-approved precision oral appliance therapy devices that are designed to treat OSA.
ProSomnus chief technology officer and co-founder Sung Kim said: “We are continuously expanding our material selection far beyond dental applications and researching and developing innovative medical grade polymers for our products.
“The improved flexibility of the ProSomnus EVO [PH] makes it even easier for patients to use, while its durability protects it from accidental drops.
“In addition to being incredibly stain-resistant, the EVO [PH] is precision milled in one piece, so it maintains its fit throughout treatment without deformation, staining or harbouring bioburden, unlike soft liner and nylon materials.”
The ProSomnus EVO [PH] Sleep and Snore Device is claimed to be the only Herbst-style device that has been developed from engineered, Medical Grade Class VI-rated material.