Tidal Medical’s Spirometer Accessory Gets Emergency Use Authorization

Dallas, Texas-based Tidal Medical Technologies has received Emergency Use Authorization from the FDA for its InSee device, an accessory used to measure respiration in hospitalized COVID-19 patients.

The device monitors respiration by attaching to Vyaire Medical's AirLife incentive spirometer, which is used to strengthen lung muscles to help patients recover from illness.

Tidal Medical is applying to the FDA for 510(k) marketing clearance for the device, which it believes can encourage more consistent use of the spirometer to improve clinical outcomes.