www.fdanews.com/articles/204594-breathesuite-gets-510k-clearance-for-otc-device-that-creates-smart-inhalers
BreatheSuite Gets 510(k) Clearance for OTC Device That Creates Smart Inhalers
September 29, 2021
Canadian respiratory health company BreatheSuite has received 510(k) clearance from the FDA for its BreatheSuite V1 metered-dose inhaler tracking device.
The system includes a disposable, battery-powered, add-on device that attaches to the top of the inhaler canister and a software application that enables remote monitoring.
The over-the-counter device monitors existing metered-dose inhalers and provides feedback on dose adherence for people with asthma and chronic obstructive pulmonary disease. The system can also share the inhaler usage patterns with healthcare professionals.