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Medical Devices / Submissions and Approvals

FDA Approves Teva’s Digital Inhaler

Jan. 4, 2019

Teva’s ProAir Digihale, a digital inhaler device that works in conjunction with a mobile app, has been approved by the FDA.

The device, which has sensors built in that detect device use and measure respiratory flow, connects to a mobile application and provides inhaler use information for patients with asthma and COPD.

The inhaler is indicated to treat or prevent bronchospasms in patients aged four years or older with obstructive airway disease, and to prevent exercise-induced bronchospasms in patients of the same age.

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