Vivos Sleep Apnea Oral Device Gets FDA Nod While Philips Wrestles With Yet Another CPAP Safety Issue

Vivos Therapeutics achieved a first in obtaining FDA clearance of its removable oral appliance for severe obstructive sleep apnea — an alternative to continuous positive airway pressure (CPAP) or surgical implants — while Philips Respironics deals with potential overheating issues in its DreamStation 2 CPAP devices.

The CARE (Complete Airway Repositioning and/or Expansion) clearance comes 11 months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA, and represents the first time the FDA granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.

Having an alternative to a CPAP machine is likely to be appealing to the users of Philips’ DreamStation 2 for whom the FDA has warned consumers to unplug the machine and do not use it if:

• There is a smell of burning, smoke, or any unusual odors;
• There is a change in the appearance of the machine;
• There are unexplained changes to the machine’s performance;
• Water is spilled into the machine; or
• The machine makes unusual sounds.
  

The warning comes after the FDA says it received more than 270 medical device reports (MDR) about the device overheating between Aug. 1 and Nov. 15, compared with fewer than 30 MDRs in the previous three years.

Read the FDA’s warning about the DreamStation 2 here.

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