HeartBeam AIMIGo with 12-L ECG Synthesis Software System

HeartBeam AIMIGo with 12-L ECG Synthesis Software System is an FDA 510(k)-cleared medical device (K250258) manufactured by Heartbeam, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 7, 2025. Regulation: 8.