FDAnews
www.fdanews.com/articles/201175-b-medicals-sleep-apnea-device-grabs-fda-clearance
ClearanceStamp_Blue.gif

3B Medical’s Sleep Apnea Device Grabs FDA Clearance

February 3, 2021

3B Medical has received FDA 510(k) marketing clearance for the third generation of its sleep apnea device, the Luna G3 Auto-BPAP.

The therapy device is used to treat obstructive sleep apnea and features an algorithm that automatically senses and adjusts pressure settings for patients to reduce the work of breathing.

The system features a new design, including integrated heated tubing, and more advanced functionality, the company said.

View today's stories