07:37 AM EDT, 09/18/2024 (MT Newswires) -- Vivos Therapeutics ( VVOS ) said Wednesday that it received the US Food and Drug Administration's 510(k) clearance for its oral medical device, which treats moderate to severe obstructive sleep apnea.
The company said the noninvasive, safe, and effective device is part of its CARE line and intended for children diagnosed with obstructive sleep apnea or snoring who need orthodontic treatment.
The approval was based on a multi-site, multi-nation study in pediatric patients.
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