Aptar Digital Health Announces FDA 510(k) Clearance for HeroTracker® Sense, a Connected Add-On Device for Metered-Dose Inhalers
AptarGroup, Inc. (ATR)
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Source: Business Wire
CRYSTAL LAKE, Ill.--(BUSINESS WIRE)--Aptar Digital Health, a global leader in digital health solutions enhancing the patient experience, 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
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Earnings
- 10/30/25 - Beat
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Sec Filings
- 11/20/25 - Form 8-K
- 11/19/25 - Form 424B5
- 11/17/25 - Form FWP
- ATR's page on the SEC website