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: March 4, 2020

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

  • 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