NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) approval empowers NuvoAir to scale and expand clinical operations to ensure no patient with heart or lung conditions is left behind.
Related: FDA approves Tyber Medical’s Mini-Frag System extension
510(k) clearance allows Air Next to conduct full spirometry at home, providing extremely valuable clinical data that ensures patients can be monitored continuously. High-quality lung data empowers the NuvoAir clinical team 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, Asthma, or ALS, using this easy-to-use 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, 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.”
By achieving 510(k) clearance, the Air Next Spirometer can now be used for ATS 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. “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.”
