AmCAD-UO

by AmCad BioMed Corporation  · Based in Taiwan → — Pioneering Ultrasound AI
Otolaryngology (ENT) Radiology Sleep Medicine

Contact for pricing
Regulatory Status Disclosed

Overview

AmCAD-UO is an innovative, AI-powered ultrasound solution developed by AmCad BioMed Corporation, designed to assist physicians in the evaluation and monitoring of Obstructive Sleep Apnea (OSA) syndrome. The system comprises a precise positioning system and a computer-assisted detection (CAD) software device. It works by acquiring multiple-angle sonographic images of the upper airway using an FDA-cleared ultrasound system. The software then automatically detects the airspace of the pharyngeal airway and computes dynamic changes to assess the risk of OSA. This non-invasive evaluation process is performed on awake patients and delivers results in approximately 10 minutes, offering an objective, accurate, cost-effective, and safe approach to OSA diagnosis.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered ultrasound analysis for Obstructive Sleep Apnea (OSA)
  • Non-invasive upper airway scanning
  • Computer-assisted detection (CAD) software
  • Automatic detection of pharyngeal airway airspace
  • Dynamic change computation of airspace for OSA risk evaluation
  • 10-minute assessment on awake patients
  • Objective, accurate, cost-effective, and safe evaluation process
  • Laser-guided positioning for precise scanning
  • 3D anatomic airway assessment
  • Standardizes ultrasound transducer scanning to reduce intra-observer variations

Use Cases

  • Evaluating the risk of Obstructive Sleep Apnea (OSA) syndrome
  • Assessing moderate/severe OSA patients
  • Identifying the root cause of sleep apnea
  • Evaluating patients for tongue reduction surgery (ENT)
  • Assessing the effectiveness of oral appliances in dentistry
  • Precision treatment and follow-up in clinical settings for OSA

What Physicians Need to Know

DICOM Support & Standards
AmCAD-UO is PACS compatible and can analyze DICOM files from ultrasound machines. The company's related products, like AmCAD-UT, support DICOM input and output (DICOM, PDF) and integration into standard reading environments.
PACS Integration Method
The system is PACS compatible, suggesting integration methods common for AI tools, such as acting as a DICOM node to receive studies via DICOM C-STORE and returning findings as DICOM Structured Reports (SR) or annotated images.
Reading Room Workflow Impact
AmCAD-UO enables quick evaluation of obstructive sleep apnea (OSA) in awake patients, providing quantitative visual assessment within approximately 10 minutes per subject from walk-in to result. This can streamline the assessment process and offer objective data for physician evaluation and monitoring.
AI Model Architecture (deep learning approach)
AmCAD-UO utilizes artificial intelligence, specifically deep learning, for its assessment reports and analysis of upper airway sonographic characteristics. AmCad BioMed is noted for pioneering ultrasound AI solutions.
Processing Speed (per study)
The system offers a rapid 10-minute detection and assessment for obstructive sleep apnea per awake patient, encompassing the entire process from scan to result.
FDA Clearance Pathway (510k/De Novo)
AmCAD-UO has received FDA 510(k) clearance.
Supported Modalities (CT/MRI/X-ray/US)
AmCAD-UO is specifically designed for use with ultrasound (US) imaging, reviewing pharyngeal/upper airway ultrasonic images.
Sensitivity & Specificity Data
A recent study highlighted AmCAD-UO's value in predicting suitable patients for hypoglossal nerve stimulation (HNS) therapy for OSA, achieving nearly 80% accuracy by combining sleep-disordered breathing severity assessment with ultrasound-based tongue tissue analysis.
RSNA/ACR Validation
While direct RSNA/ACR validation for AmCAD-UO is not explicitly stated, AmCad BioMed has published research and clinical evidence on its ultrasound AI technologies and has collaborated with institutions like Stanford Sleep Medicine Center.
Physician Tip

AmCAD-UO provides a rapid, non-invasive, and quantitative assessment of the upper airway for Obstructive Sleep Apnea (OSA) in awake patients, taking approximately 10 minutes. This can significantly expedite initial evaluations and aid in patient selection for various OSA treatments, including advanced therapies like hypoglossal nerve stimulation, by offering objective anatomical and functional insights. Physicians should integrate the AI-powered assessment as a supportive tool for evaluation and monitoring, not as a standalone diagnostic. The system's ability to standardize ultrasound transducer scanning also helps reduce operator-dependent variations, leading to more consistent assessments.

AmCAD-UO is designed to be PACS compatible, facilitating integration into existing radiology workflows. Its ability to analyze DICOM files from various ultrasound systems ensures broad compatibility. For optimal utility, consider integrating the AI-generated reports and quantitative data directly into the PACS and potentially the Electronic Health Record (EHR) system to ensure a seamless flow of information and comprehensive patient records. This integration can help radiologists and referring clinicians access critical OSA assessment data efficiently within their established viewing and reporting environments.

Details

Category Radiology & Imaging AI
Pricing Contact for pricing — N/A
DeploymentPC-based software application, integrated with FDA-cleared ultrasound systems
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

AmCAD-UO received FDA 510(k) clearance (K180867) on December 28, 2018. It is classified under 21 CFR 892.2050, Picture Archiving And Communications System, product code LLZ. The software is intended for reviewing pharyngeal/upper airway ultrasonic images acquired from FDA-cleared ultrasound systems to support visualization and quantification of airway sonographic characteristics for physician evaluation and monitoring.

Integrations
EHR Not specified
Specialties Otolaryngology (ENT), Radiology, Sleep Medicine

What the Web Says

AmCAD-UO is an AI-powered ultrasound system designed to assist physicians in evaluating the risk of Obstructive Sleep Apnea (OSA) by scanning the patient's neck and analyzing the upper airway. It provides a 3D reconstruction of the airway and an AI-powered assessment report, predicting the risk of severe sleep apnea. The process is objective, accurate, cost-effective, and safe, taking about 10 minutes for awake patients. The system has also shown promise in predicting suitable patients for hypoglossal nerve stimulation (HNS) therapy with nearly 80% accuracy.

Overall: Positive

Strengths

  • AI-powered assessment for objective and accurate results.
  • Non-invasive and radiation-free imaging.
  • Quick evaluation process (around 10 minutes) for awake patients.
  • Provides a 3D reconstruction of the upper airway for a comprehensive view.
  • Potential to evaluate CPAP alternatives and assess effectiveness of therapies.
  • Useful for ENT practices, surgeons, and dentists to examine patient anatomy.

Limitations

  • Sleep medicine practitioners may lack training in ultrasonography, raising questions about its immediate clinical role in this subspecialty.
  • Must not be used alone for primary diagnostic interpretation.
  • Limited information available from independent tech reviewers, Reddit, G2, or Capterra specifically for AmCAD-UO. (No direct mentions found in search results)
  • Some general employee reviews for AmCad (the parent company) mention unstable work environment, low pay, and poor work-life balance.

Based on reviews from: Sleep Review, Taiwan Excellence Award, Commercial Times, Indeed.com, Stanford Medicine

Last updated: 2026-07-18

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Videos

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

View all on YouTube

Frequently Asked Questions

AmCAD-UO is an AI-powered ultrasound system designed for the rapid, non-invasive assessment of the upper airway in awake patients to evaluate the risk and root cause of Obstructive Sleep Apnea (OSA). It provides a 3D anatomical view of the airway and can calculate the Apnea-Hypopnea Index (AHI), assisting physicians in treatment evaluation and patient selection for therapies like hypoglossal nerve stimulation.
AmCAD-UO is cleared by the FDA to provide data for a physician's evaluation and monitoring of patients' airways. However, it is explicitly stated that AmCAD-UO must not be used alone for primary diagnostic interpretation of obstructive sleep apnea.
Unlike overnight polysomnography (PSG), AmCAD-UO offers a quick, 10-minute, non-invasive assessment on awake patients, providing immediate 3D anatomical insights into the upper airway. While PSG remains the gold standard for definitive diagnosis, AmCAD-UO serves as a valuable tool for screening, risk assessment, and evaluating treatment options by visualizing physical anatomy.
Specific pricing for AmCAD-UO is not publicly disclosed in the provided search results. However, as an AI-powered medical device, acquisition costs would typically include the ultrasound system and its specialized software, along with potential ongoing subscription or maintenance fees. Practices should also consider costs for staff training and integration with existing electronic health record systems.
While AmCAD-UO aims to standardize ultrasound scanning, physicians and staff would require training on the specific device operation, laser-guided positioning, and interpretation of the AI-generated assessment reports. For sleep medicine specialists, this may involve new training in ultrasonography, as it is not traditionally part of their certification.
A key limitation is that AmCAD-UO cannot be used as a standalone tool for primary OSA diagnosis; it is intended to provide data for physician evaluation. Additionally, the integration into clinical sleep medicine practices may face challenges due to the lack of existing ultrasonography training for many sleep specialists.

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