Asthmapolis wins FDA clearance for new sensor and software | Regulatory Roundup
Asthmapolis receives 510(k) clearance for a new asthma sensor and software for a companion app.
Asthmapolis obtains clearance for new sensor and app software
The FDA granted Asthmapolis 510(k) clearance for a new sensor that sits atop an inhaler, records every use of the inhaler and transmits the information to an app on the user's mobile device(s). The software that runs the app received FDA approval as well.
Keeping track of usage patterns, including frequency of use and length of use, will help both asthma patients and their doctors better manage the condition.