New York City-based Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer. The Bluetooth-connected device measures critical lung function with comparable accuracy to clinical-grade spirometers, and sends the data to a smartphone or tablet.
Cohero Health has already been using the spirometer as part of its medication adherence tracking platform in a pilot at Mount Sinai Medical Center. By using both a spirometer and an inhaler sensor, Cohero is able to not only track inhaler usage, but make connections between inhaler usage and lung function.
“Because we track the use of the controller medication, we can also track the use of the rescue inhaler and track the resulting changes in lung function,” cofounder and COO Daniel Weinstein told MobiHealthNews last fall. “By combining those three things we can do some really cool predictive analytics. From the patient-specific standpoint we can tell this patient’s headed for an adverse event, or we can say ‘Hey this patient has been taking his medicine the way he’s supposed to, but he’s not getting better. Maybe the doctor needs to change the prescription.’ We can also do some cool macro level things, we can track [whether] certain sub-populations do better or worse on a particular drug, and that’s useful for pharma. So we’ve gotten a lot of interest from pharma to monitor patient populations on their product.”
Specifically, the spirometer allows users to track their lung function at home, not just in clinic, with more accuracy than a peak-flow meter, which is currently the standard of care for at-home lung function monitoring. And while the peak-flow meter only tracks maximum speed of exhalation, the spirometer tracks Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV1), the speed and volume of breath over time.
Cohero Health’s newly cleared device connects to the company's pediatric and adult mobile applications, AsthmaHero and BreatheSmart respectively, to log and provide feedback on results. Both applications also deliver customized medication reminders to patients, and track use of both maintenance and rescue medication via inhaler sensors. The company's software then tracks and analyzes the effects of maintenance and rescue medication use, along with external triggers, on lung function.
The company says early pilot results have shown a 250 percent increase in medication adherence, and 100 percent reduction in hospitalizations. Cohero Health plans to launch additional pilots ahead of full commercial launch of their full platform later this year.