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Air Next Spirometer Cleared by the FDA for Asthma, COPD

The FDA has granted 510(k) clearance to the Air Next spirometer for patients with severe lung conditions like Asthma and COPD.

The Air Next is a simple, handheld, Bluetooth-connected spirometer that allows asthma patients to easily test lung function and assess lung symptoms.

501(k) clearance is granted by the FDA when medical devices that are about to be introduced to the market demonstrate safety and efficacy that is at least “substantially equivalent,” to currently approved devices.

NuvoAir boasts a 95% adherence rate from a pilot study showing that 19 of 20 patients continued using Air Next after 1 year.

Data gathered by the Air Next spirometer can be used by patients to monitor disease progression, shared with patients’ medical teams, and accessed by hospital clinicians to monitor lung health.

 

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