Minneapolis-based startup Nuvaira Inc. has received breakthrough device designation from the U.S. FDA for its Dnerva lung denervation system to reduce the risk of moderate-to-severe exacerbations of chronic obstructive pulmonary disease (COPD) in patients receiving optimal care. The bronchoscopic procedure works by disrupting pulmonary nerve input to the lung, improving symptoms and […]
Tag: breakthrough designation
Vapotherm Oxygen Assist Module Granted FDA Breakthrough Device Designation
Vapotherm, Inc. has announced that the FDA recently granted Breakthrough Device Designation for the Company’s Oxygen Assist Module (OAM). FDA’s Breakthrough Device Program is intended to help patients and healthcare providers receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis of […]





