> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Anumana Gets Breakthrough on ECG-AI Algorithm
- URL: https://www.fdaweb.com/anumana-gets-breakthrough-on-ecg-ai-algorithm/
- Published: 2023-06-21T12:00:00.000Z
- Updated: 2026-09-14T18:40:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154735

FDA has granted Anumana a breakthrough device designation for its ECG-AI algorithm, which is designed to aid the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed cause of heart failure. “The use of AI algorithms to identify subtle signals in \[electrocardiograms\] ECGs that are imperceptible to humans stands to transform cardiovascular medicine by allowing us to detect disease early, in more easily treated stages,” the company says. Anumana says it plans to conduct a retrospective clinical validation trial and pursue an FDA *de novo* classification for the algorithm as “software as a medical device.”

Cardiac amyloidosis is an underdiagnosed disease that often leads to heart failure, according to the company. Diagnosing this condition early can be difficult because of disease rarity and that it often presents with nonspecific signs and symptoms. “While a standard ECG is obtained during the evaluation of these nonspecific symptoms, human interpretation of the ECG often misses subtle combinations of features that may indicate cardiac amyloidosis,” it says.