# Anumana Inc. (manufacturer, Cambridge, MA): 2 new FDA device listings, incl. cardiac amyloidosis machine learning-based notification software

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Anumana Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Cambridge, MA, US |
| New listings | 2 |
| Devices | Cardiac Amyloidosis Machine Learning-Based Notification Software; Pulmonary Hypertension Machine Learning-Based Notification Software |
| Product codes | SHP, SAT |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm; ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm |
| First new listing | 2026-10-07 |
| Latest new listing | 2026-10-07 |
| FDA registration number | 3029762850 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.