Anumana, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040), ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020), ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Anumana, Inc. Cardiovascular ✕
5 devices
Cleared
Apr 07, 2026
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
Cardiovascular
130d
Cleared
Mar 28, 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Cardiovascular
242d
Cleared
Jul 28, 2025
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Cardiovascular
146d
Cleared
Nov 25, 2023
NeuTrace EP Mapping System v.2.1
Cardiovascular
59d
Cleared
Sep 28, 2023
Low Ejection Fraction AI-ECG Algorithm
Cardiovascular
23d