![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Vivos Sleep Apnea Oral Device Gets FDA Nod While Philips Wrestles With Yet Another CPAP Safety Issue
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.
To read the whole story, click here to subscribe.
Related Topics
Upcoming Events
-
11Jul
-
18Jul
-
21Oct