NuvoAir Medical announced its Air Next spirometer has received 510(k) clearance from the US Food and Drug Administration for in-home use as a full spirometer.

The clearance allows Air Next to conduct full spirometry at home, providing clinical data that ensures patients can be monitored continuously, according to a release from the company. High-quality lung data empowers clinical teams to intervene when changes are detected and provide instantaneous care before lung function deteriorates to the point where hospitalizations are necessary.

For patients with conditions like COPD and asthma, using this device at home means they don’t have to wait for an in-person appointment or plan the logistics for travel.

“Air Next is capable of providing our care team with high-quality lung measurements from the comfort of our patients’ homes,” says Eric Harker, MD MPH MBA, chief medical officer at NuvoAir, in a release. “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.”

By achieving 510(k) clearance, the Air Next spirometer can be used for American Thoracic Society 2019-compliant spirometry in clinical trials across the US and Europe.

“Air Next brings the reliability of in-clinic spirometry right to our patients’ hands,” says Furat Shawki, general manager of clinical trials at NuvoAir, in a release. “With in-home approval….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.”

Photo caption: Air Next spirometer

Photo credit: NuvoAir Medical