Aptar Digital Health today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HeroTracker® Sense as a Class II medical device. This milestone recognizes HeroTracker® Sense – a Bluetooth-enabled sensor – as an innovative connected add-on for pressurized Metered Dose Inhalers (pMDIs), transforming traditional inhalers into smart, data-driven devices for patients and healthcare professionals.
Designed for individuals aged 12 and above, HeroTracker® Sense 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. Integrated within Aptar Digital Health’s Respiratory Disease Management Platform, HeroTracker® Sense supports users in managing their respiratory health through comprehensive medication and symptom management. The platform delivers real-time usage tracking, personalized reminders and educational resources via an intuitive mobile application, encouraging behavior change and adherence to prescribed therapies. By enabling patients to monitor inhaler techniques and receive instant feedback, the platform aims to support improved respiratory health.
“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[1]. The U.S. FDA’s clearance allows us to enable broader access to our connected solutions for patients seeking to better manage their respiratory health.”
Asthma remains a significant health concern in the United States, affecting an estimated 26.8 million people across the United States[2]. It stands among the leading causes of missed school and workdays, contributing to an economic burden of nearly $82 billion each year in medical costs, lost productivity and premature death. With the FDA clearance of HeroTracker® Sense, individuals living with asthma or COPD will now have access to an innovative and user-friendly solution for tracking, evaluating and recording their medication use, aiming to improve treatment outcomes and quality of life.
About HeroTracker® Sense
HeroTracker® Sense is a connected add-on device attached to a compatible pressurized Metered Dose Inhaler (pMDI) for patients aged 12 and above. 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. HeroTracker® Sense is designed to operate with specific pMDI and medication indicated on the label. It does not provide information on the remaining quantity of medication in the inhaler and does not include a dose-counting function. HeroTracker® Sense does not provide spirometry measurements. HeroTracker® Sense may be used in clinical practice or clinical trials, where specialists require insights into whether a patient has used their prescribed medication or to assess inhalation technique.
Download full Press Release.
[1] Bijlani A, Mauger D, Goodheart C, dOrsay G, Suman J. Impact of a digital therapeutic on adult asthma. Eur J Public Health. 2023 Oct 24;33(Suppl 2):ckad160.823. doi: 10.1093/eurpub/ckad160.823. PMCID: PMC10597004.
