Heartbeam, Inc. · Class II · Cleared Dec 8, 2025
| K-number | K250258 |
| Device name | HeartBeam AIMIGo with 12-L ECG Synthesis Software System |
| Applicant | Heartbeam, Inc. |
| Product code | DXH |
| Device class | Class II |
| Decision date | Dec 8, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.2920 |
The HeartBeam AIMIGo System with 12-L ECG Synthesis Software is a portable, non-invasive recorder that captures a 3-lead ECG from 5 electrodes and synthesizes a 12-lead ECG display for manual interpretation of non-life-threatening arrhythmias (normal sinus rhythm, sinus arrhythmia, tachycardia, bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complexes). It is for adult use in clinical or home settings and does not perform automated analysis or replace standard 12-lead ECGs.
Both the subject device and predicate (HomeTrak Plus EASI) record 3-channel ECGs and synthesize 12-lead outputs using linear transformation matrices. Key differences: subject uses 5 dry electrodes versus predicate's 5 wet EASI-configuration electrodes; subject uses wireless Bluetooth/BLE communication versus predicate's cable-based connection; subject displays results via cloud-based clinician portal versus predicate's central analysis center. Both are prescription-only, non-single-use devices with identical intended use for arrhythmia assessment only.
Software verification and validation per IEC 62304:2006; human factors and usability testing per IEC 62366-1 and FDA Human Factors Guidance (February 3, 2016); cybersecurity testing per Section 524B(b)(2) of the FDCA and FDA Cybersecurity Guidance (June 27, 2025); general system-level verifications per design specifications.
The subject device is substantially equivalent because both the subject and predicate devices share the same intended use—recording 3-lead ECGs and deriving 12-lead outputs for manual assessment of non-life-threatening arrhythmias—and employ comparable technological methods (linear transformation matrices). Nonclinical and clinical testing (127 patients in pivotal study, 45 in positioning validation study) demonstrated clinical equivalence between synthesized and reference standard 12-lead ECGs. Technological differences (electrode type, communication method, portal interface) do not raise new safety or effectiveness questions, as performance is substantially equivalent for the stated indications.
View the full FDA submission: accessdata.fda.gov