The US Food and Drug Administration (FDA) has granted 510(k) clearance to NuvoAir for the in-home use of its Air Next spirometer.
The spirometer allows individuals to conduct comprehensive lung function tests from their own homes, providing data for continuous monitoring of conditions such as chronic obstructive pulmonary disease (COPD), asthma and amyotrophic lateral sclerosis (ALS).
The clearance also allows the Air Next spirometer to be utilised in clinical trials, adhering to standards set by the American Thoracic Society (ATS) in 2019 for spirometry testing. Researchers will be able to gather data from participants in their own homes, allowing for more frequent and consistent monitoring of respiratory patients.
In the announcement accompanying the approval, NuvoAir chief medical officer Eric Harker said: “Spirometry has traditionally been underutilised 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.”
According to a model on GlobalData’s Medical Device Intelligence Center, the US spirometer market will be worth $47.5m in 2030, growing at a compound annual growth rate (CAGR) of 4.5% from $30.7m in 2020.
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By GlobalData
Last September, India-based alveofit (Roundworks Technologies) gained FDA approval for its portable digital spirometer, alveoair, for distribution in the US. The spirometer offers healthcare professionals with immediate insights into respiratory health, facilitating timely interventions.
These insights, combined with predictive analytics and artificial intelligence (AI), allow clinicians to prioritise cases and deliver quality care tailored to individual patient needs.
In May 2023, telemedicine solutions provider CMI Health launched an app-based asthma-management platform called AsthmaGo, which is designed to be paired with medical devices and various smart oximeters to provide users with a clear and precise view of their daily lung performance and oxygen saturation levels.
