The US Food and Drug Administration (FDA) has given 510(k) clearance to 3B Medical Inc’s third generation bilevel device, the Luna G3 Auto-BPAP.
The Luna G3 Auto BPAP, for the treatment of obstructive sleep apnea, available with integrated heated tubing, cellular connectivity, and 3B’s algorithm that automatically senses and adjusts pressure settings. The Luna G3 Auto-BPAP provides a backup rate that reduces the work of breathing with pressure settings up to 25 cmH20, according to the company.
[RELATED: Switching to Bilevel PAP Saves 56% of Patients from Therapy Termination]
“We are excited by FDA’s recent action approving use of the Luna G3 Auto-BPAP. The Luna G3 is 3B Medical’s third generation platform and incorporates a new design, a smaller footprint, and more advanced functionality,” says Justin Smith, 3B Medical’s chief operating officer, in a release. “The Luna G3 Auto-BPAP delivers noninvasive ventilatory support with all of the bells and whistles that DMEs have come to expect from 3B Medical.”