FDA Approves Bronchoscopic Therapy For COPD And Asthma
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
The U.S. Food and Drug Administration (FDA) has granted approval to Nuvaira® Lung Denervation System which has been designated as a Breakthrough Device.

The Nuvaira lung denervation system enables a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which causes airway hyper-responsiveness or “lung attacks” in both COPD and asthma.

The system is designed to reduce the risk of worsening moderate-to-severe chronic obstructive pulmonary disease (COPD) in patients on optimal medical care, according to Minneapolis-based Nuvaira.

In March, the FDA’s review of safety data on the first 50 patients enrolled in Nuvaira’s Airflow-3 pivotal trial resulted in FDA investigational device approval for the company to complete the 400-patient study, Nuvaira noted.

Source: https://www.massdevice.com/nuvaira-gains-fda-breakthrough-nod-for-lung-denervation-system/
D●●●●i D●●●●●●●●a and 4 others like this3 shares
Like
Comment
Share