3B Medical’s Luna G3 receives approval
By HME News Staff
Updated 10:23 AM CST, Tue February 2, 2021
WINTER HAVEN, Fla. – 3B Medical has received 501(k) clearance from the U.S. Food and Drug Administration for its new third-generation bi-level device, the Luna G3 Auto-BPAP, to treat obstructive sleep apnea. The device is available with integrated heated tubing, cellular connectivity, and an advanced algorithm that automatically senses and adjusts pressure settings to ensure airway patency, according to the company. “We are excited by the FDA’s recent action approving use of the Luna G3 Auto-BPAP,” said Justin Smith, 3B Medical’s COO. “The Luna G3 is 3B Medical’s third generation platform and incorporates a new design, a smaller footprint and more advanced functionality.” The device also provides a backup rate that reduces the work of breathing with pressure settings up to 25 cmH20, the company says.
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