Cardiac Amyloidosis AI Notification
Flags a rare heart disease that is routinely mistaken for ordinary heart failure.
Cardiac amyloidosis is a disease where abnormal protein stiffens the heart muscle. It looks like ordinary heart failure, it is treated differently, and it is missed constantly.
This is exactly the shape of problem trained models are good at. A rare pattern, buried in a common presentation, that a clinician might see a handful of times in a career and a model can learn from thousands of cases.
One product has cleared here. Treat this as an early field rather than a mature one.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- SHP
- FDA name for it
- Cardiac Amyloidosis Machine Learning-Based Notification Software
- Rule number
- 21 CFR 870.2380
- Risk class
- Class 2
- Medical field
- Cardiovascular
Before You Sign Anything
- Ask what confirmatory testing a flag triggers, and whether you can access it locally.
- Ask how many flags you should expect per year at your volume. For a rare disease the honest answer may be very few, and that is fine if the treatment changes.
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | April 7, 2026 | K253801 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.