CRYSTAL LAKE, Ill. — Aptar Digital Health, a global leader in digital health solutions designed to enhance the patient experience, announced that the U.S. Food and Drug Administration has granted 510(k) clearance for HeroTracker Sense as a Class II medical device. The Bluetooth-enabled sensor converts traditional pressurized metered-dose inhalers (pMDIs) into smart, data-driven tools to help patients and healthcare professionals better manage respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD).
Designed for individuals aged 12 and older, HeroTracker Sense is compatible with several widely prescribed medications, including Ventolin HFA, Advair, and specific albuterol and fluticasone/salmeterol inhalers. Integrated into Aptar Digital Health’s Respiratory Disease Management Platform, the device enables users to track inhaler use in real time, receive personalized reminders, and access educational content through a companion mobile application. The platform supports adherence and behavioral change while offering healthcare providers actionable data on patient engagement and inhaler technique.
“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, Senior Vice President of 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.”
Asthma affects an estimated 26.8 million people in the United States and remains a leading cause of missed school and workdays, contributing to an annual economic burden of nearly $82 billion in medical costs, lost productivity, and premature deaths. With the FDA clearance of HeroTracker Sense, Aptar Digital Health aims to provide individuals living with asthma or COPD a modern, easy-to-use solution to monitor medication use, improve treatment adherence, and enhance overall quality of life.
