HeartBeam has initiated a pilot study to evaluate its on-demand 12-lead electrocardiogram (ECG) patch in patients with suspected coronary artery disease.
The study is taking place at two hospitals in Belgrade, Serbia, and marks a key stage in the development of the HeartBeam patch, which aims to assist in ischemia detection outside clinical environments.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Designed to extend cardiac monitoring beyond hospital settings, the patch is currently being investigated and is not yet cleared by the US Food and Drug Administration (FDA).
It follows HeartBeam’s earlier card-sized device and uses 3D ECG technology to capture the heart’s electrical signals from three non-coplanar dimensions.
With continuous single-lead ECG recording, patients can activate a full synthesised 12-lead ECG by placing two fingers on the patch, thus enabling clinicians to receive high-quality cardiac data when symptoms arise.
The study will enrol around 50 patients at high risk for coronary artery disease whose resting ECGs do not show signs of ischemia.
All participants will perform exercise stress tests, followed by the immediate activation of the HeartBeam patch to record a synthesised 12-lead ECG.
These recordings will be compared to standard ECGs administered at the same time, and findings will inform HeartBeam’s broader regulatory plans.
HeartBeam CEO Robert Eno said: “Ischemia detection has not been possible on patch-based ambulatory monitors, and they do not provide clinical-grade insights over an extended period of time. The HeartBeam patch is designed to change that.
“A device capable of generating an on-demand 12-lead ECG at the moment symptoms occur — wherever the patient may be — could fundamentally expand the role of ambulatory cardiac monitoring beyond rhythm assessment alone.
“Entering a $2bn market with established reimbursement is compelling on its own. Adding ischemia detection as a capability makes the opportunity significantly larger.”
The study also supports the patch as a core HeartBeam growth initiative, alongside the limited launch for arrhythmia assessment, future expansions for heart attack detection, and advancement of its AI programme.
In December 2025, HeartBeam secured FDA clearance for its 12-lead ECG synthesis software, setting the arrhythmia assessment tool up for deployment in patients’ homes.
