BreatheSuite today announced that it has received FDA 510(k) clearance for its BreatheSuite metered-dose inhaler (MDI) V1 device.
BreatheSuite designed the device to turn existing MDIs into smart inhalers by automatically monitoring and providing feedback on inhaler adherence and technique for people with asthma and COPD. It has a disposable, battery-powered, portable MDI add-on and a mobile application based on behavior change strategies.
The BreatheSuite system connects to the top of a canister of an inhaler. In combination with the mobile app, the device can evaluate and score a patient’s inhaler technique and usage patterns. It stores the results in the cloud to allow a patient to track and use the information to improve how they use an inhaler.
“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,” founder and CEO Brett Vokey said in a news 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 U.S.”
Information on the cloud from the device can also be shared remotely to allow doctors to monitor and promote a customizable care plan for each patient.
“By having a real-time way to digitally monitor and provide feedback to patients, we hope to enhance healthcare outcomes,” chief scientific officer Meshari Alwashmi said. “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.”
BreatheSuite’s device is compatible with 90% of MDIs currently on the market. In addition, it does not interfere with regular MDI usage and can be removed and reattached to new inhalers.