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EchoGo Pro

Ultromics

Outcomes-based AI system that predicts coronary artery disease.

Information source: Vendor
Last updated: November 24, 2021

General Information

General
Product name	EchoGo Pro
Company	Ultromics
Subspeciality	Cardiac
Modality	Ultrasound
Disease targeted	Coronary Artery Disease
Key-features	Risk prediction, automated segmentation
Suggested use	During: interactive decision support (shows abnormalities/results only on demand), report suggestion After: diagnosis verification

Technical Specifications

Data characteristics
Population	All stress echo indications in adults
Input	Stress Echo
Input format	DICOM
Output	PDF Report with key quantification and findings
Output format	PDF
Technology
Integration	Integration in standard reading environment (PACS), Integration via AI marketplace or distribution platform, Stand-alone webbased
Deployment	Locally virtualized (virtual machine, docker), Cloud-based
Trigger for analysis	Automatically, right after the image acquisition
Processing time	10 - 60 seconds

Regulatory

Certification
CE	Certified, Class I , MDD
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)	5.1. Intended Use Based on an echocardiogram, indicate whether there is evidence of disease as an aid to diagnosis. 5.2. Indication for Use EchoGo Pro v1.0.6 is a machine learning-based decision support system, indicated as an adjunct to diagnostic stress echocardiography for patients undergoing assessment for coronary artery disease (CAD). When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis. Patient management decisions should not be made solely on the results of the EchoGo Pro v1.0.6 analysis. EchoGo Pro v1.0.6 is to be used with stress echo exam protocols that contain A2C, A4C and mid[1]ventricular short-axis views at rest and at peak stress. EchoGo Pro v1.0.6 is not intended for the assessment of mild or moderate myocardial ischemia, localization of coronary artery disease, for the assessment of myocardial perfusion, myocardial viability, or valve disease.

Market

Market presence
On market since	03-2020
Distribution channels	Caption Health
Countries present (clinical, non-research use)	2
Paying clinical customers (institutes)	1
Research/test users (institutes)	2
Pricing
Pricing model	Pay-per-use, Subscription
Based on	Number of analyses

Evidence

Evidence
Peer reviewed papers on performance
Non-peer reviewed papers on performance	Automated Coronary Artery Disease Prediction (read)
Other relevant papers