Smartphone connected spirometer gets FDA Approval

Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer that measures critical lung function with comparable accuracy to clinical-grade spirometers, and sends the data to a smartphone or tablet.

The spirometer allows users to track their lung function at home with more accuracy than a peak-flow meter, which is currently used for at-home lung function monitoring. And while the peak-flow meter only tracks maximum speed of exhalation, the spirometer tracks Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV1), the speed and volume of breath over time.

The spirometer is currently being used as part of a medication adherence tracking platform in a pilot at Mount Sinai Medical Center.

Posted in Apps, Regulation, Software Development, Technology, Validation