The FDA has granted 510(k) clearance to Aptar Digital Health’s HeroTracker Sense MDI sensor, the company said. Aptar acquired the sensor’s developer, Cohero Health, in 2020 and launched the Bluetooth-enabled sensor in 2022.
According to the company, the HeroTracker Sense has the ability to monitor actuation, shake, orientation, and coordination, as well as duration and strength of inspiration. The device is compatible with several MDIs for asthma and COPD, including Ventolin HFA and Advair, and connects with Aptar Digital Health’s Respiratory Disease Management Platform.
Aptar Digital Health Senior VP, Global Quality and Regulatory Affairs, Raffi Krikorian commented, “By combining inhalation therapy with advanced digital health solutions, we aim to support patients in improving adherence and providing healthcare professionals with actionable insights. Our platform has previously shown promise in supporting asthma management and reducing reliance on rescue medication. The US FDA’s clearance allows us to enable broader access to our connected solutions for patients seeking to better manage their respiratory health.”
Read the Aptar press release
