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Aptar Digital Health's HeroTracker Sense Gains FDA 510(k) Clearance

Key highlights
  • HeroTracker Sense is a Bluetooth-enabled sensor for pMDIs.
  • It is compatible with asthma and COPD medications like Ventolin HFA and Advair.
  • The device supports users aged 12 and above in managing respiratory health.
  • Asthma affects 26.8 million people in the U.S., costing nearly $82 billion annually.

FDA Clearance

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for HeroTracker Sense, classifying it as a Class II medical device. This Bluetooth-enabled sensor transforms traditional pressurized Metered Dose Inhalers (pMDIs) into smart devices.

Device Compatibility

HeroTracker Sense is designed for individuals aged 12 and above and is compatible with several commonly prescribed asthma and COPD medications, including Ventolin HFA, Advair, and certain albuterol and fluticasone/salmeterol inhalers.

Functionality and Features

Integrated within Aptar Digital Health’s Respiratory Disease Management Platform, HeroTracker Sense offers real-time usage tracking, personalized reminders, and educational resources through a mobile application. It monitors inhaler techniques, providing instant feedback to support improved respiratory health.

Impact on Respiratory Health

Asthma affects an estimated 26.8 million people in the United States, contributing to an economic burden of nearly $82 billion annually. The FDA clearance of HeroTracker Sense aims to provide individuals with asthma or COPD a user-friendly solution for tracking and evaluating medication use, potentially improving treatment outcomes and quality of life.