Anumana ECG-AI AI
Anumana · anumana.ai ↗
ECG-AI algorithms that detect low ejection fraction and other cardiac conditions from a 12-lead ECG.
AI status
AI product On FDA AI-enabled device list (K250652) · source
Compliance profile
| Field | Status | Detail | Source | Checked |
|---|---|---|---|---|
| FDA | Verified | 510(k) cleared · K250652 | accessdata.fda.gov | 2026-10-14 |
| HIPAA | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| BAA | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| SOC 2 | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| HITRUST | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| Epic integration | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
Vendor-stated means the claim appears on the vendor’s site; we have not audited it. Unverified means we found no source, which is not a negative finding. Vendors can request a correction.
FDA records
From the FDA AI-enabled medical devices list. Wording follows FDA: 510(k) “cleared”, De Novo “granted”. Clearance applies to the specific indication in the FDA record.
| Number | Device (as listed) | Pathway | Decision date | Panel |
|---|---|---|---|---|
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | 510(k) cleared | 07/28/2025 | Cardiovascular |
| K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | 510(k) cleared | 04/07/2026 | Cardiovascular |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | 510(k) cleared | 03/28/2026 | Cardiovascular |
Alternatives
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