Company Spotlight: Ultromics EchoGo Amyloidosis (1.0) - Finding Disease in the Echo

We unpack the FDA 510(k) summary for EchoGo Amyloidosis 1.0, an AI screening tool by Ultromics designed to detect cardiac amyloidosis from routine echocardiograms. We break down its performance numbers, how it handles uncertain data, and the demographic gaps in its testing dataset.

Key points

• EchoGo Amyloidosis 1.0 is an AI tool cleared to screen for cardiac amyloidosis in heart failure patients aged 65 and over.
• It analyzes a standard apical four-chamber 2D echocardiogram without contrast.
• In a retrospective testing dataset of 1,164 patients, it achieved 84.5% sensitivity and 89.7% specificity.
• The software rejects 14.0% of scans as too uncertain to classify, which protects overall accuracy but means those patients need alternative evaluation.
• Performance varies across demographics, with sensitivity dropping to 73.9% in female patients and 68.8% in patients with a body mass index over 35.

Source: FDA 510(k) summary K240860: EchoGo Amyloidosis (1.0) (Ultromics) - U.S. Food and Drug Administration, 2024

This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Company: Ultromics (ultromics.com) · Product: EchoGo Amyloidosis (1.0) · FDA 510(k) K240860

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/company-spotlight-ultromics-echogo-amyloidosis-1-0-finding-disease-in-8b189f