Device Tracker
FDA-Cleared AI Devices in Cardiology
Echocardiography analysis, ECG-derived risk models, and coronary imaging physiology.
| Device | Manufacturer | Route | Year | Modality | Function |
|---|---|---|---|---|---|
| Anumana ECG-AI LEF | Anumana | 510(k) | 2022 | ECG | Flags likely low ejection fraction from a standard ECG |
| Caption Guidance | Caption Health | De Novo | 2020 | Echocardiography | Coaches a clinician to acquire diagnostic-quality echo images |
| Cleerly | Cleerly | 510(k) | 2019 onward | Coronary CT angiography | Quantifies coronary plaque volume and composition |
| EchoGo | Ultromics | 510(k) | 2020 onward | Echocardiography | Automated echocardiographic measurement and analysis |
| Eko Low EF | Eko Health | FDA authorized | 2024 | ECG and digital stethoscope | Point-of-care detection of low ejection fraction |
| HeartFlow FFRct Analysis | HeartFlow | FDA authorized | 2014 | Coronary CT angiography | Computes coronary fractional flow reserve from CT |
| Tempus ECG-AF | Tempus | FDA authorized | 2024 | ECG | Estimates near-term atrial fibrillation risk from ECG |
| Us2.v1 | Us2.ai | 510(k) | 2022 | Echocardiography | Fully automated echocardiogram reporting |