FDA clears oral device for sleep apnea from Vivos Therapeutics

The mRNA oral appliance for treating obstructive sleep apnea. [Image courtesy of Vivos Therapeutics]Vivos Therapeutics (Nasdaq:VVOS) announced today that the FDA cleared its removable CARE oral devices for treating obstructive sleep apnea (OSA).

The CARE (complete airway repositioning and/or expansion) line includes the flagship DNA, mRNA and mmRNA oral appliances. Littleton, Colorado-based Vivos says its clearance makes it the first company bringing a clear alternative to CPAP or neurostimulation implants to market to treat OSA.

The state of the sleep apnea treatment space remains up in the air amid the major device recall at Philips. A new wrinkle was added to the mix yesterday when the FDA warned of thermal issues with certain Philips CPAP devices.

ResMed took hold of the sleep respiratory market as Philips still works through the recall. However, the company had its own struggles, leading to layoffs and an overall operating model shift. Inspire Medical,…

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