The Food and Drug Administration has cleared the BreatheSuite Metered-Dose Inhaler (MDI) V1 device, designed to turn existing MDIs into smart inhalers.

The BreatheSuite System consists of a disposable, battery-powered, portable BreatheSuite MDI add-on device and the BreatheSuite App. The BreatheSuite MDI device is attached to the top of the canister of the patient’s inhaler and works together with the mobile app to monitor and provide feedback on inhaler adherence and technique. The device, which is approved for both prescription and over-the-counter use, is able to provide the following feedback to users: 

  • Measure how long the patient shakes their inhaler.
  • Sense if the inhaler’s mouthpiece is horizontal.
  • Measure how long the patient inhales.
  • Sense if the patient pushed down on the inhaler as they start to breathe in.
  • Record the date and time of each use.

Additionally, with the patient’s consent, data gathered on the mobile app may be shared with health care professionals to optimize therapy and identify patients who need additional assistance. 

Regular use of the MDI is not affected by the device, which can be removed and reattached to a new inhaler. The add-on device is compatible with 90% of MDIs on the market.

“By having a real-time way to digitally monitor and provide feedback to patients, we hope to enhance healthcare outcomes,” said Dr Meshari F. Alwashmi, Chief Scientific Officer, BreatheSuite. “Furthermore, having an objective measure of adherence and technique from each user with asthma and [chronic pulmonary obstructive disease] will advance the sphere of knowledge regarding the effectiveness of inhaled medications.”


  1. BreatheSuite receives FDA clearance for over-the-counter device to turn regular metered-dose inhalers into smart inhalers. News release. BreatheSuite Inc. September 28, 2021. Accessed September 29, 2021.
  2. BreatheSuite MDI. BreatheSuite. Accessed September 28, 2021.