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Designation for treating Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD).
Beyond Air, Inc. (Nasdaq: XAIR) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its LungFit® GO system. The designation is for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD), a serious and often chronic lung infection.
The FDA's Breakthrough Device Designation program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
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