FDA clears add-on device that turns MDIs into smart inhalers


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 portable, battery-powered BreatheSuite MDI companion device and the BreatheSuite app. The BreatheSuite MDI device is attached to the top of the patient’s inhaler cartridge and works with the mobile app to monitor and provide information on inhaler adhesion and technique. The device, which is approved for prescription and over-the-counter use, is able to provide the following feedback to users:

  • Measure how long the patient is shaking their inhaler.
  • Detect whether the mouthpiece of the inhaler is horizontal.
  • Measure how long the patient inhales.
  • Feel if the patient is pressing down on the inhaler when they start to breathe in.
  • Note the date and time of each use.

Additionally, with patient consent, data collected on the mobile app can be shared with healthcare professionals to optimize treatment and identify patients who need further assistance.

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


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“By having a real-time way to digitally monitor and provide feedback to patients, we hope to improve healthcare outcomes,” said Dr. Meshari F. Alwashmi, Scientific Director of BreatheSuite. “In addition, having an objective measure of the adherence and technique of each asthmatic user and [chronic pulmonary obstructive disease] will advance the knowledge sphere regarding the efficacy of inhaled drugs.

The references

  1. BreatheSuite receives FDA clearance for an over-the-counter device that turns ordinary metered-dose inhalers into smart inhalers. Press release. BreatheSuite Inc. September 28, 2021. Accessed September 29, 2021. https://www.breathesuite.com/post/breathesuite-receives-fda-clearance-for-over-the-counter-device-to-turn-regular- inhalers -dosers-in-inhalers-smart.
  2. BreatheSuite MDI. BreatheSuite. Accessed September 28, 2021. https://www.breathesuite.com/.


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