Beyond Air submits FDA PMA supplement for LungFit PH

Beyond Air (XAIR) announced the submission of a premarket approval, PMA, supplement application to the U.S. Food and Drug Administration, FDA, for LungFit PH II, the next-generation therapeutic nitric oxide generator. Beyond Air has developed its LungFit PH II system to be smaller, lighter and fully transport-ready – while delivering all the breakthrough features of the currently FDA-approved version from the Company’s therapeutic platform of nitric oxide generators targeting pulmonary disease. The new system uses the same Smart Filter and accessories as the first-generation device, ensuring continuity, streamlined logistics, and minimal disruption for existing customers.