HeartBeam Earns FDA Clearance for 12-Lead Synthesis Software for Assessing Arrhythmia

▤ Summary

HeartBeam secured FDA 510(k) clearance for its cable-free 12-lead ECG synthesis software that captures cardiac signals in three non‑coplanar dimensions and generates a clinical 12‑lead ECG. The synthesized ECGs can be obtained by patients outside the clinic and are reviewed promptly by on‑demand, board‑certified cardiologists. The company plans a limited U.S. commercial introduction in early 2026 with select concierge and preventive cardiology practices and will validate real‑world performance at reference sites. HeartBeam also intends to pursue a heart attack detection indication, develop an extended‑wear 12‑lead patch prototype, and leverage longitudinal 3D ECG data to build AI screening and prediction algorithms.

▦ Linked Companies

HeartBeam, Inc.

$1M to $5M