FDA-Cleared AI Directory
Cardiovascular AI Cleared by the FDA
Heart and vessel AI that watches for one named condition and raises a hand. Each product here is cleared for one specific warning.
Cardiovascular AI took a different shape from radiology. Instead of one tool reading everything, the FDA has been clearing narrow products that each watch for a single condition and send a notification when they see it.
Low ejection fraction. Pulmonary hypertension. Atrial fibrillation risk. Cardiac amyloidosis. Each one is its own device type with its own clearance, which is why this field has many types and few products in each.
The practical effect is that you cannot buy one heart AI. You buy a specific warning, for a specific condition, off a specific input. Ask which one before anything else.
Device Types in Cardiovascular
The FDA sorts cleared AI into named device types. Each one has its own bar to clear, so the type tells you what the product is allowed to claim.
| Device type | What it is allowed to do | Cleared | Latest |
|---|---|---|---|
| Low Ejection Fraction AI Notification | Reads an ECG and flags patients whose hearts may be pumping weakly, before anyone has ordered a heart scan. | 5 | September 19, 2025 |
| Pulmonary Hypertension AI Notification | Flags signs of high blood pressure in the lung arteries, a condition usually found years late. | 3 | August 21, 2026 |
| Cardiovascular Machine Learning Notification Software | Watches heart data for a pattern and sends an alert, without saying what the pattern means. | 2 | June 8, 2026 |
| Adjunctive Coronary Physiology Indicator | Estimates how much a narrowing actually restricts blood flow, from imaging rather than from a wire in the artery. | 1 | September 8, 2023 |
| Atrial Fibrillation Risk Prediction AI | Predicts which patients are likely to develop an irregular heartbeat, before it has happened. | 1 | June 21, 2024 |
| Cardiac Amyloidosis AI Notification | Flags a rare heart disease that is routinely mistaken for ordinary heart failure. | 1 | April 7, 2026 |
| Coronary Artery Disease AI Notification | Flags patients whose data suggests narrowed heart arteries, for a clinician to follow up. | 1 | September 8, 2023 |
| Hypertension AI Notification | Flags patterns suggesting high blood pressure that has not been picked up or is not controlled. | 1 | September 11, 2025 |
Newest Cardiovascular Clearances
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| Tempus ECG-PH | Tempus AI, Inc. | August 21, 2026 | K253699 |
| EchoNext | Pathwai, Inc. | June 8, 2026 | K260332 |
| ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | April 7, 2026 | K253801 |
| ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | March 28, 2026 | K252360 |
| Bunkerhill ECG-EF | BunkerHill Health | September 19, 2025 | K250649 |
| Hypertension Notification Feature (HTNF) | Apple, Inc. | September 11, 2025 | K250507 |
| ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | July 28, 2025 | K250652 |
| Tempus ECG-Low EF | Tempus AI, Inc. | July 15, 2025 | K250119 |
| Tempus ECG-AF | Tempus AI, Inc. | June 21, 2024 | K233549 |
| CorVista System with PH Add-On | Analytics For Life, Inc. | April 5, 2024 | K233666 |
| Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | March 28, 2024 | K233409 |
| Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | September 28, 2023 | K232699 |
| Cleerly ISCHEMIA | Cleerly, Inc. | September 8, 2023 | K231335 |
| CorVista® System | Corvista Health, Inc. | September 8, 2023 | K232686 |
| Viz HCM | Viz. Ai, Inc. | August 3, 2023 | DEN230003 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance is a regulatory decision about a product, not a recommendation, and it does not measure how well the product works in your own setting. Confirm the current status and the exact cleared indication on the FDA record before you buy.