BreatheSuite Gets 510(k) Clearance for OTC Device That Creates Smart Inhalers
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.