Company overview
HeartHero is a Denver-based medical device company founded in 2016 by Gary Montague. Its principal product is Elliot, a portable automated external defibrillator designed for use in homes, workplaces, community settings and while travelling.
Elliot combines automated rhythm analysis and shock delivery with voice and visual guidance. A companion HeartHero app supports device management and readiness monitoring; the company says the app is not required to operate the AED during a rescue.
The company is commercializing internationally while pursuing U.S. market access. Australia has an active ARTG entry naming HeartHero as manufacturer, and the company reports CE-marked availability in Europe and the UK. HeartHero states that Elliot is not FDA approved or available for U.S. sale; its March 2026 announcement reports a PMA application accepted for review.
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Activity & Milestones
6 events2026-03-11 · RegulatoryElliot PMA submission and FDA review acceptance announced
HeartHero reported that its Elliot PMA application had been submitted and accepted for FDA review. The date shown is the announcement date; submission acceptance is not approval, and no FDA decision date or PMA reference was established. [10]
2025 · CommercializationInternational launch reported
An October 2026 company anniversary post dates Elliot’s international launch to October 2025. This describes the company’s reported launch, not its first regulatory authorization. [17]
2022-05-02 · RegulatoryAustralian ARTG inclusion
ARTG 387771 lists a non-rechargeable public AED manufactured by HeartHero Inc, sponsored by Emergo Australia, with Australian device classification IIb. [19]
2020-02-12 · PartnershipAmerican College of Cardiology collaboration announced
ACC and HeartHero announced a collaboration focused on out-of-hospital cardiac arrest and access to defibrillation. This was a collaboration announcement, not FDA authorization. [9]
2019-07-24 · FundingSeries A financing closes
The company announced an oversubscribed Series A round supporting manufacturing and regulatory submissions. COPIC was named as an investor; the release did not disclose the round amount. [11]
2018-07-10 · Funding$1.5 million seed financing announced
HeartHero announced a $1.5 million seed financing package involving venture and angel investment and grant funding, including support from PIC Investment Group and Colorado OEDIT. [18]
