Aptar Digital Health Wins FDA Nod for Smart Add-on for Inhalers

Aptar Digital Health, a digital health solutions company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its HeroTracker Sense as a Class II medical device.

The milestone recognizes HeroTracker Sense, a Bluetooth-enabled sensor, as a connected add-on for pressurized metered dose inhalers (pMDIs). It transforms traditional inhalers into smart, data-driven devices for patients and clinicians.

It functions as an electronic data capture accessory for monitoring and recording individual inhalation actuation, shake, orientation, coordination, and inspiratory strength and duration during prescribed inhaler use.

The technology is compatible with several commonly prescribed asthma and chronic obstructive pulmonary disease (COPD) medications, including Ventolin HFA, Advair, and certain albuterol and fluticasone/salmeterol inhalers. It’s designed for people age 12 and above.

HeroTracker Sense supports users in managing their respiratory health through comprehensive medication and symptom management. The platform provides real-time usage tracking, personalized reminders, and educational resources via a mobile app, aiming to encourage behavior change and adherence to prescribed therapies.

“By combining inhalation therapy with advanced digital health solutions, we aim to support patients in improving adherence and providing healthcare professionals with actionable insights,” said Raffi Krikorian, SVP Global Quality and Regulatory Affairs at Aptar Digital Health. “Our platform has previously shown promise in supporting asthma management and reducing reliance on rescue medication. The FDA’s clearance allows us to enable broader access to our connected solutions for patients seeking to better manage their respiratory health.”