Us2.v1

Us2.ai

Us2.ai supports cardiovascular disease diagnostics by providing machine learning based solutions that analyze and interpret echocardiograms, which are ultrasound images of the heart, creating patient reports, at scale, on mobile, on premises and cloud-based platforms.

Information source: Vendor
Last updated: September 4, 2024

General Information

General
Product name	Us2.v1
Company	Us2.ai
Subspeciality	Cardiac
Modality	Ultrasound
Disease targeted	Heart disease, Pulmonary Hypertension
Key-features	Automated measurements include 2-dimensional (cardiac volumes, all 4 chambers of the heart), M-mode (e.g. tricuspid annular plane systolic excursion), spectral Doppler (blood flow across all valves, both PW and CW measurements) and tissue Doppler
Suggested use	During: perception aid (prompting all abnormalities/results/heatmaps), report suggestion

Technical Specifications

Data characteristics
Population	Vast majority of adult transthoracic echocardiograms. Not intended for reporting measurements associated with valve disease, pericardial disease, or right-sided hemodynamics (e.g. estimated pulmonary artery systolic pressure); intra-cardiac lesions (e.g. tumours, thrombi); and will not report measurements for complex adult congenital heart disease.
Input	Transthoracic echocardiography
Input format	DICOM
Output	Patient report, editable image annotations, comparison to international reference guidelines
Output format	DICOM SR, PDF, CSV
Technology
Integration	Integration in standard reading environment (PACS), Integration CIS (Clinical Information System), Integration via AI marketplace or distribution platform, Stand-alone third party application, Stand-alone webbased
Deployment	Locally on dedicated hardware, Locally virtualized (virtual machine, docker), Cloud-based, Hybrid solution
Trigger for analysis	Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time	1 - 10 minutes

Regulatory

Certification
CE	Certified, Class IIb , MDR
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)	Us2.v1 is a software platform that automatically processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, producing a full report with measurements of several key cardiac structural and functional parameters. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision- making. Us2.v1 is indicated for use in adult patients. Us2.v1 has not been validated for the assessment of congenital heart disease, valve disease, pericardial disease, and/or intra- cardiac lesions (e.g. tumours, thrombi).

Market

Market presence
On market since	06-2022
Distribution channels	Blackford, Aidoc aiOS, Viz Platform, Eureka Clinical AI, Nuance PIN
Countries present (clinical, non-research use)	USA, Canada, EU, Australia, New Zealand, Singapore
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Subscription
Based on	Number of analyses

Evidence

Evidence
Peer reviewed papers on performance	Concordance of left ventricular volumes and function measurements between two human readers, a fully automated AI algorithm, and the 3D heart model (read) Point‑of‑care AI‑enhanced novice echocardiography for screening heart failure (PANES‑HF) (read) Artificial intelligence-assisted automated heart failure detection and classification from electronic health records (read) Nurse-led home-based detection of cardiac dysfunction by ultrasound: results of the CUMIN pilot study (read) External validation of a deep learning algorithm for automated echocardiographic strain measurements (read) A formal validation of a deep learning-based automated workflow for the interpretation of the echocardiogram (read) Automated interpretation of systolic and diastolic function on the echocardiogram: a multicohort study (read)
Non-peer reviewed papers on performance
Other relevant papers	OPERA-AI: Artificial Intelligence Reporting of Handheld Echocardiography in Suspected Heart Failure (read) Democratizing Echocardiography with Augmented Intelligence (read)