Fierce Biotech November 29, 2023
In much the same way that they’re designed to expand wearers’ upper airways, Vivos Therapeutics’ slate of oral appliances have now expanded their FDA indications, too.
Collectively known as the Complete Airway Repositioning and/or Expansion (CARE) devices, the mouthpieces are newly cleared to help treat severe obstructive sleep apnea, or OSA, in adults, Vivos announced Wednesday. They’d previously racked up clearances in mild-to-moderate cases of the condition.
According to the devicemaker, the FDA nod in severe OSA is the first for an oral appliance and also makes the CARE devices the first “clear alternative treatment” to standard CPAP machines and surgical implants for severe cases of the condition.
“This achievement is a pivotal milestone for Vivos, and elevates our proven...
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