Key Takeaways HeartBeam secured FDA clearance for its cable-free synthesized 12-lead ECG system.The approval followed a successful appeal that overturned a prior NSE decision.The company plans a limited U.S. launch in early 2026 through concierge and preventive cardiology groups.HeartBeam (BEAT) recently secured FDA 510(k) clearance for its first-of-its-kind, cable-free synthesized 12-lead ECG technology, marking a major inflection point in the company’s mission to modernize cardiac diagnostics. The approva ...