NuvoAir’s Air Next Spirometer OK’ed for Home Use

NuvoAir Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Air Next spirometer to be used at home.
 
The clearance lets Air Next conduct full spirometry at home, providing clinical data for patients to be monitored continuously. This lung data allows the NuvoAir clinical team to intervene when changes are spotted and provide instant care before lung function deteriorates to the point of hospitalization.
 
For conditions like COPD, asthma, or ALS, the company said using the device at home means they don’t have to travel, wait for an in-person appointment, or plan logistics for travel.
 
“Air Next is capable of providing our care team with high-quality lung measurements from the comfort of our patients’ homes,” said Eric Harker, MD MPH MBA, and chief medical officer at NuvoAir. “Spirometry has traditionally been underutilized as a diagnostic and monitoring tool because of the logistical challenges of getting complex patients to a clinic with regularity. In-home spirometry empowers our practice to provide continuous care to our patients in the home with real-time, high-quality, and actionable clinical data.”
 
“Air Next brings the reliability of in-clinic spirometry right to our patients’ hands,” added Furat Shawki, GM of clinical trials at NuvoAir. “With in-home approval of ATS 2019-compliant spirometry, we can look forward to scaling our services with our partners across the healthcare ecosystem, including healthcare providers and clinical trials, so we can deliver the cardiopulmonary care that people desperately deserve to the places that need it most.”