Fisher & Paykel Gains 510(k) Clearance for its Evora Full Face Mask for Sleep Apnea

Fisher & Paykel Healthcare has received the FDA’s 510(k) clearance for its F&P Evora Full, a compact full-face mask for the treatment of obstructive sleep apnea.

The mask features a floating seal located under the nose to provide patients with a clear line of sight, while stability wings keep the seal stable.

In clinical trials, 96 percent of participants were able to sleep in their preferred sleeping position and most users rated the mask as “comfortable” or “very comfortable.”

The mask, which is already marketed in Europe, Canada, Australia and New Zealand, will now be launched in the U.S. market, the Auckland, New Zealand-based company said.