BreatheSuite announces FDA clearance of device that turns inhalers into smart inhalers
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BreatheSuite announced that it received 510(k) clearance from the FDA for its Metered-Dose Inhaler V1 device, which turns existing inhalers into smart inhalers for people with asthma and COPD, according to a company press release.
The BreatheSuite device is approved for prescription and over the counter use, according to the release.
The device turns existing metered-dose inhalers by automatically and objectively monitoring and providing feedback on inhaler adherence and technique, according to the release.
The BreatheSuite system is composed of a disposable, battery-powered, portable metered-dose inhaler add-on device and a mobile application based on behavior change strategies. The system is designed to work with a metered-dose inhaler by attaching to the top of the canister of a patient’s inhaler. The device and mobile app then work together to evaluate and score a person’s inhaler technique and usage patterns; results are stored in the cloud for tracking purposes so patients can use the information to improve their inhaler use and for the patients’ health care team to create customizable care plans, according to the release.
Inhaler techniques, including shaking the inhaler 10 to 15 times, breath timing and positioning, have a great impact on the amount of medication administered, according to the release. Moreover, for every 100 patients using an inhaler, 90 are using it incorrectly and 66 are not adhering to the medication as prescribed by their physician, according to the release.
“By having a real-time way to digitally monitor and provide feedback to patients, we hope to enhance health care outcomes,” Meshari F. Alwashmi, PhD, chief scientific officer at BreatheSuite, said in the release. “Furthermore, having an objective measure of adherence and technique from each user with asthma and COPD will advance the sphere of knowledge regarding the effectiveness of inhaled medications.”
“We are extremely excited to have obtained FDA clearance, which is a critical step in achieving our vision of improving the lives of respiratory patients worldwide,” Brett Vokey, founder and CEO of BreatheSuite, said in the press release. “The COVID-19 pandemic has underscored that now is the time for remote patient monitoring to take a front seat in providing better, more transparent care for all people with asthma or COPD. With FDA clearance, we are poised to become a leader in providing actionable insights to people with asthma or COPD across the United States.”