FDA Reviewing Premarket Application for a Connected Automated External Defibrillator

HeartHero’s Premarket Approval (PMA) application for Elliot—a connected automated external defibrillator (AED) categorized as a Class III medical device—has been accepted for review by the U.S. Food and Drug Administration (FDA), the company announced.

For cardiac arrests, the weakest link in the chain of survival has always been time to shock. When an AED shock is delivered within three minutes, the chance of survival is more than 70%. However, in the time it takes for Emergency Medical Services to arrive with an AED, it’s often too late. For decades, defibrillator deployment strategies centered primarily on buildings, yet approximately 80% of sudden cardiac arrests occur in the home, where immediate access to defibrillators has not been readily available.

“In trauma, time allows transport. In cardiac arrest, time determines survival. Having our Class III PMA accepted for review reflects our commitment to meeting the most stringent regulatory standards while expanding access wherever seconds matter most,” HeartHero Founder/CEO and former CIA medical officer Gary Montague said.

Elliot is engineered to reduce time to shock while remaining practical for daily environments, including family homes. Weighing slightly more than a pound, the device provides guided voice prompts to assist bystanders during cardiac emergencies and analyzes heart rhythm to deliver a shock when clinically appropriate. Elliot operates on CR123 lithium batteries, including store-bought Duracell options, eliminating a dependence on proprietary power systems and supporting long-term readiness in both residential and community settings.

The device integrates with a companion mobile application that enhances user confidence through training resources, device status reporting, and readiness monitoring, reinforcing preparedness beyond the moment of emergency. HeartHero is currently selling and distributing units in the United Kingdom and Australia.

The FDA’s Premarket Approval pathway is widely regarded as the global gold standard for medical device quality. PMA requires extensive clinical and engineering evidence, validated manufacturing controls, and a comprehensive review of safety and effectiveness data. Acceptance for review confirms that a device has met the FDA’s threshold for full scientific evaluation under these rigorous standards. Review timelines are determined by the agency as part of its regulatory process.

HeartHero has secured CE Mark certification in the European Union and the United Kingdom, is registered with Australia’s Therapeutic Goods Administration (TGA), and operates under United Kingdom regulatory oversight through the Medicines and Healthcare products Regulatory Agency (MHRA). Australian surf lifesaving champion Guy Leech has partnered with HeartHero to accelerate community awareness initiatives following his longstanding advocacy for early defibrillation access.

“More than a decade ago, I lost a close mate, Chucky, to sudden cardiac arrest,” Leech stated. “Increasing immediate access to defibrillation is not theoretical. It is personal. Expanding access across communities is how we change outcomes.”

Founded in 2016, HeartHero is developing connected automated external defibrillators to improve survival outcomes in sudden cardiac arrest. Its flagship device, Elliot, is a connected AED designed to reduce time to shock by expanding access to early defibrillation across homes, communities, workplaces, and public environments.