AmCAD-UT®

AmCad BioMed

AmCAD-UT® Detection gives physicians a tool to process ultrasound images for sonographic characteristics that assist in making diagnostic decisions. AmCAD-UT® Detection uses statistical pattern recognition and quantification methods to perform analytical processing of images. By processing the image for key characteristics (i.e., echogenic foci, echogenicity, texture, margin, anechoic areas, height/width ratio, nodule shape, and nodule size). AmCAD-UT® Detection provides physicians with quantification and visualization of the sonographic characteristics for informed decision making.

Information source: Vendor
Last updated: November 20, 2024

General Information

General
Product name	AmCAD-UT®
Company	AmCad BioMed
Subspeciality	Head/Neck
Modality	Ultrasound
Disease targeted	Thyroid cancer, Thyroid nodule
Key-features	Automated nodule recognition, quantification and visualization of sonographic features, risk analysis based on global guidelines
Suggested use	Before: stratifying reading process (non, single, double read), flagging acute findings During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand), report suggestion

Technical Specifications

Data characteristics
Population	Thyroid ultrasound scanning for thyroid nodule
Input	2D grayscale ultrasound images
Input format	DICOM, BMP, JPEG or TIFF
Output	Visualized and quantified sonographic features, recommendation based on TI-RADS and global guidelines including AACE/ACE/AME, ACR , ATA, EU-TIRADS, BTA, Kwak et al., KSThR and KSR, ) and Seo et al.
Output format	DICOM, pdf
Technology
Integration	Integration in standard reading environment (PACS), Integration via AI marketplace or distribution platform, Stand-alone webbased
Deployment	Locally on dedicated hardware, Cloud-based
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	< 3 sec

Regulatory

Certification
CE	Certified, Class IIa , MDD
FDA	510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE)

Market

Market presence
On market since	2017
Distribution channels
Countries present (clinical, non-research use)	13
Paying clinical customers (institutes)	4 countries
Research/test users (institutes)	12 countries
Pricing
Pricing model	Pay-per-use, Subscription
Based on	Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance	Improving the diagnostic strategy for thyroid nodules: a combination of artificial intelligence-based computer-aided diagnosis system and shear wave elastography (read) Multi-Reader Multi-Case Study for Performance Evaluation of High-Risk Thyroid Ultrasound with Computer-Aided Detection (read) Diagnostic Performance Evaluation of a Computer-Assisted Imaging Analysis System for Ultrasound Risk Stratification of Thyroid Nodules (read) Study on the comparison of diagnostic of K-TIRADS, ACR-TIRADS and ATA in CAD and diagnosis of thyroid nodules by computer-assisted ultrasonography (read)
Non-peer reviewed papers on performance
Other relevant papers