HeartBeam Tests On-Demand 12-Lead ECG Patch for Ischemia Detection in Pilot Study

Event summary

  • HeartBeam initiated a pilot study for its on-demand 12-lead ECG patch, targeting ischemia detection outside clinical settings.
  • The study will enroll 50 patients at two hospitals in Belgrade, Serbia, comparing synthesized 12-lead ECGs with standard 12-lead ECGs post-exercise.
  • The patch leverages HeartBeam’s patented 3D ECG technology, designed to capture cardiac signals from three non-coplanar dimensions.
  • The patch-based ambulatory cardiac monitoring market is valued at approximately $2 billion with established reimbursement pathways.

The big picture

HeartBeam’s pilot study represents a strategic push to expand cardiac monitoring beyond rhythm assessment, targeting a $2 billion market. The initiative aligns with broader trends in decentralized healthcare, where portable, on-demand diagnostic tools are increasingly valued. Success could position HeartBeam as a key player in ambulatory cardiac monitoring, particularly if the patch gains FDA clearance for ischemia detection.

What we're watching

Regulatory Strategy
How the pilot study results will shape HeartBeam’s broader regulatory strategy for the ECG patch.
Market Disruption
Whether the patch can disrupt the long-term continuous monitor and mobile cardiac telemetry markets.
Technology Validation
The pace at which HeartBeam can validate its 3D ECG technology for ischemia detection in real-world settings.

Related topics

Medical Devices