The Luna G3 Bilevel S/T 30Vt was granted 510(k) clearance by the US FDA for use as a noninvasive ventilator (NIV), according to manufacturer React Health.
The new clearance expands use of the device beyond the sleep disordered breathing (SDB) space into management of chronic respiratory conditions, React says.
“We are pleased that the FDA has approved the expanded use of the Luna G3 Bilevel S/T 30Vt as a noninvasive ventilator,” said Clint Geffert, React Health’s President of Commercial Operations.
“React Health remains committed to the successful treatment of Chronic Sleep and Respiratory Diseases and this approval further strengthens our offerings to help improve the lives of millions of patients suffering from these conditions. The Luna G3 Bilevel S/T joins our growing portfolio of respiratory products and offers prescribers and providers options at a time when recalls and supply chain challenges have impacted market availability of devices,” Geffert added.