FDA Approval of First and Only Digital Inhaler with Built-In Sensors

The Food and Drug Administration (FDA) has approved ProAir Digihaler (albuterol sulfate) inhalation powder for the treatment or prevention of bronchospasm in patients aged 4 years and older with reversable obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. The approval was based on the review of a supplemental New Drug Application (sNDA). 

ProAir Digihaler, Teva Pharmaceuticals, is the first digital inhaler with built-in sensors that connects to a mobile application and provides data on inhaler use to patients with asthma and chronic obstructive pulmonary disease (COPD). The product combines a breath-activated, multi-dose dry powder inhaler with albuterol along with a built-in electronic module and a companion app. The sensors detect and record when the inhaler is used and measure inspiratory flow; this data is then sent to the companion application via Bluetooth Wireless Technology so patients can review their data and share it with their healthcare professionals.