Vivos Therapeutics Stock Is Moving Higher On FDA Approval For Its Sleep Apnea Device

Vandana Singh
1 min read
0
In this article:

  • The FDA has granted 510(k) clearance to Vivos Therapeutics Inc's (NASDAQ: VVOS) mmRNA (modified mandibular Repositioning Nighttime Appliance) obstructive sleep apnea (OSA) device.

  • The device is indicated for mild to moderate OSA, sleep-disordered breathing, and snoring in adults.

  • The approval paves the way for expanded insurance reimbursement coverage for the mmRNA device and potential future government contracts and reimbursement.

  • Separately, the FDA has denied Vivos' previously submitted, additional 510(k) application for its DNA appliance.

  • The DNA appliance is already registered with the FDA as a Class I device for palatal expansion and is currently being used by Vivos-trained clinicians accordingly.

  • Vivos expects to appeal the FDA's decision or resubmit the 510(k) application to the FDA in the coming weeks.

  • Related: Suffers' Lose Sleep After Philips' Recall Of Sleep Apnea Machine: WSJ.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: VVOS shares are up 41.9% at $5.45 during the premarket session on the last check Monday.

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