AmCAD-UV

by AmCad BioMed Corporation  · Based in Taiwan → — Pioneering Ultrasound AI
Cardiology Radiology Vascular Surgery

Not available
Regulatory Status Disclosed

Overview

AmCAD-UV is a software device developed by AmCad BioMed Corporation, specializing in AI-powered ultrasound solutions for medical diagnostics. It is designed for quantifying and classifying ultrasonic color intensity data acquired from FDA-cleared ultrasound systems. The tool displays noise-reduced, color-coded pulsatile signals, which can assist users in interpreting variations in the hemodynamic properties of blood vessels. AmCAD-UV functions as a general-purpose medical image processing tool for vascular pulsatility analysis and is intended for prescription use. It is important to note that it must not be used alone for primary diagnostic interpretation. The software processes dynamic flow Doppler ultrasound images in DICOM, Bitmap, or JPEG formats and is compatible with Windows XP or higher operating systems, including Windows Embedded and DICOM-compliant medical devices. The company, founded in 2008 and headquartered in Taipei, Taiwan, holds multiple FDA and CE certifications for its range of AI ultrasound products.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Quantifies and classifies ultrasonic color intensity data
  • Displays noise-reduced color-coded pulsatile signals
  • Differentiates between pulsatile signals and noise
  • Simultaneously displays quantified intensities of differentiated signals
  • User-friendly interface for setting signal detection sensitivity
  • Exports quantified values in text format
  • Exports color-coded pulsatile images and waveform trend charts in Bitmap format
  • Displays dynamic intensity information as color-coded images
  • Enhances contrast and reduces noise in images
  • Utilizes proprietary algorithms for noise reduction

Use Cases

  • Assisting interpretation of hemodynamic property variations in blood vessels
  • Vascular pulsatility analysis using flow Doppler ultrasound images
  • General-purpose medical image processing for ultrasound diagnostics

What Physicians Need to Know

Vascular Pulsatility Analysis
AmCAD-UV is an image analysis software designed to quantify and classify ultrasonic color intensity data from FDA-cleared ultrasound systems. It displays noise-reduced pulsatile signals, assisting in the interpretation of hemodynamic properties of blood vessels.
Noise Reduction Capabilities
The software incorporates proprietary algorithms to differentiate between pulsatile signals and noise, effectively reducing interference caused by motion artifacts and other sources.
Regulatory Clearance
AmCAD-UV holds FDA 510(k) and CE Mark Clearance.
Data Export Functionality
The system allows for the export of quantified values of classified pulsatile signals in text format.
Diagnostic Support Role
It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis and should not be used alone for primary diagnostic interpretation.
Real-Time Alert Capability
Real-time alert capabilities are not specified for AmCAD-UV in the context of cardiovascular events; its function is image analysis.
Physician Tip

Utilize AmCAD-UV as a supplementary tool for detailed vascular pulsatility analysis from ultrasound images, enhancing the interpretation of hemodynamic variations in blood vessels. Remember that it is intended to assist, not replace, primary diagnostic interpretation. Its ability to quantify and visualize pulsatile signals can provide objective data to support clinical decision-making regarding vascular health.

AmCAD-UV is a software device that processes ultrasonic color intensity data from FDA-cleared ultrasound systems. It can export quantified pulsatile signal values in text format, suggesting potential for integration with other medical imaging systems or electronic health records for data archiving and further analysis, similar to Picture Archiving and Communication Systems (PACS) software.

Details

Category Cardiology AI, Radiology & Imaging AI
Pricing Not available — Not available
DeploymentOn-premise (Windows-based PC/workstation, tablet PC)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

AmCAD-UV received FDA 510(k) clearance (K170069) on April 26, 2017. It is classified as a Picture Archiving and Communications System (PACS) software device (21 CFR 892.2050, Product Code LLZ) and is intended for prescription use.

Integrations
EHR Not specified
Specialties Cardiology, Radiology, Vascular Surgery

Ratings & Reviews

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Clinical Value
Ease of Use
Integration
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Value for Money

Press & Coverage

AmCad BioMed Corporation
AmCad BioMed Corporation Obtains CE Marking on an Innovative Product 'AmCAD-UV'
AmCad BioMed Corporation announced that it has obtained CE Marking for its innovative product, AmCAD-UV, which will initially be used for the early detection of breast cancers.
2016-05
accessdata.fda.gov
FDA 510(k) Clearance for AmCAD-UV
AmCAD-UV, a software device for classifying ultrasonic color intensity data from flow Doppler ultrasound images, received FDA 510(k) clearance in April 2017. It is intended as a general-purpose medical image processing tool for vascular pulsatility analysis.
2017-04
MDPI
Artificial Intelligence in Translational Medicine
This peer-reviewed article discusses the rapid adoption of AI in healthcare, mentioning AmCAD-UV as an AI tool for classifying ultrasonic color intensity data from flow Doppler ultrasound images, with a K170069 clearance in Radiology in April 2017.
2021-11
PMC
The Diagnostic Efficiency of Ultrasound Computeru2013Aided Diagnosis in Differentiating Thyroid Nodules: A Systematic Review and Narrative Synthesis
This systematic review includes AmCAD-UV (Doppler CAD) in a discussion of different thyroid ultrasound CAD systems, noting its use with FNAC/Histopathology and Doppleru2013quantitative intranodular vascularization.
2019-11
PMC
Mature AI/ML-Enabled Medical Tools Impacting Vascular Surgical Care: A scoping review of late-stage, FDA approved/cleared technologies relevant to vascular surgeons
This review identifies AmCAD-UV as one of 17 mature AI/ML-enabled technologies with FDA clearance relevant to vascular surgery, approved in 2016. It classifies ultrasound color intensity data for vascular pulsatility analysis.
2023-09
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u4ee4u548c4u5e74u5ea6 AIu30fbu30e2u30d0u30a4u30ebu7528u30a2u30d7u30eau30b1u30fcu30b7u30e7u30f3u7b49 u6700u5148u7aefu533bu7642u6a5fu5668u8abfu67fbu7b49u4e8bu696d u5831u544au66f8 u4ee4u548c5u5e74
This Japanese regulatory report lists AmCAD-UV from AmCad BioMed Corporation as an AI/ML medical device in Radiology, with an FDA database entry from April 6, 2017.
2022-08
Scribd
Cat Hospitalar17
This document mentions AmCAD-UV as having a CE Mark for classifying pulsatile signals, alongside other AmCAD products aimed at early detection and diagnosis of various cancers and diseases.
2026-02

Videos

Product demos, reviews, and walkthroughs for AmCAD-UV.

View all on YouTube

Frequently Asked Questions

AmCAD-UV is an image analysis software designed for interpreting ultrasound imaging of blood vessels. Its primary clinical application is vascular pulsatility analysis, providing classified color-coded pulsatile signals to assist in understanding hemodynamic properties.
AmCAD-UV functions as a post-acquisition image processing tool, working with images from FDA-cleared ultrasound systems. It allows physicians to delineate a specific region of interest for analysis and view dual images of original and color-coded pulsatile signals, augmenting their interpretation.
Yes, AmCAD-UV has received FDA 510(k) clearance and CE Mark clearance. This indicates it has met the necessary regulatory standards for marketing and use as a medical device in the respective regions.
AmCAD-UV is intended as a general-purpose medical image processing tool for vascular pulsatility analysis and must not be used alone for primary diagnostic interpretation. The images with classified color-coded signals displayed on AmCAD-UV should assist, but not replace, a physician's final diagnosis.
While direct, functionally identical alternatives to AmCAD-UV for specific vascular pulsatility analysis were not explicitly detailed, other advanced medical imaging software or PACS systems may offer general image processing and analysis capabilities. These systems often provide tools for viewing, storing, and sharing medical images, which could include some level of vascular assessment.
AmCAD-UV's software development follows documented processes for design, verification, and validation testing, including risk assessments to identify potential hazards. As an FDA-cleared device, it adheres to regulatory requirements for medical devices, which typically include provisions for data integrity and safety.
Specific pricing for AmCAD-UV is not publicly disclosed, with AmCad BioMed indicating that prices are indicative only and may vary by country, excluding additional charges. Interested parties are advised to contact a supplier directly for a quote, suggesting a customized or direct sales model rather than standardized public licensing tiers.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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