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.
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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.
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The company personalises and digitally manufactures the device based on each patient’s unique anatomy and treatment plan.
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By GlobalDataProSomnus’ 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.
