MEDO-Thyroid

by Exo Inc. (formerly MEDO DX Pte.)  · Based in United States → — Revolutionizing Thyroid Ultrasound with AI
Endocrinology Otolaryngology (ENT) Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

MEDO-Thyroid is an artificial intelligence (AI) software designed to drastically simplify the workflow for thyroid ultrasound scanning. It operates as a cloud-based standalone Software as a Medical Device (SaMD) intended for use with adult patients (18 years or older). The tool takes video sweeps of the thyroid gland as input and leverages AI to automatically review the data, select optimal images for analysis, and calculate standard lobe and isthmus measurements. It further assists in locating, measuring, and characterizing any thyroid nodules present, utilizing the well-known Thyroid Imaging Reporting and Data System (TI-RADS). The software culminates in the creation of individualized, interactive reports, aiming to make thyroid ultrasound examinations faster, more objective, and less prone to error.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered automatic image selection from video sweeps
  • Automatic calculation of standard thyroid lobe and isthmus measurements
  • Assistance in locating, measuring, and characterizing thyroid nodules
  • Utilizes TI-RADS system for nodule characterization and risk scoring
  • Generates individualized, interactive examination reports
  • Cross-referencing ability for viewing nodules across multiple planes (transverse and sagittal)
  • Cloud-based standalone Software as a Medical Device (SaMD)
  • Simplifies ultrasound workflow for faster and more objective analysis
  • Aids in analysis of thyroid lobes and identification of thyroid nodules
  • Compatible with Digital Imaging and Communications in Medicine (DICOM) images from ultrasound scanners

Use Cases

  • Simplifying and accelerating thyroid ultrasound scanning workflow
  • Assisting radiologists in evaluating and quantifying thyroid ultrasound images
  • Generating comprehensive and consistent reports for thyroid ultrasound examinations
  • Efficiently following up on multiple thyroid nodules
  • Reducing scan-to-report time for diagnostic imaging
  • Improving consistency and reducing errors in thyroid imaging and diagnosis

What Physicians Need to Know

Key Capabilities
Simplifies thyroid ultrasound workflow by automatically reviewing data, selecting optimal images, and calculating lobe/isthmus measurements. It assists in locating, measuring, and characterizing thyroid nodules using the TI-RADS system, including volumetric data for scoring. The tool also offers a cross-referencing ability for nodules across multiple planes, similar to CT and MRI, and generates individualized, interactive reports.
Clinical Utility
Aids in rapid and objective diagnosis of thyroid nodules, making ultrasound examinations less complex and more consistent for radiologists and technologists. It is particularly helpful for managing multiple nodules and has the potential to increase patient throughput and reduce unnecessary follow-up testing. The technology also aims to lower the expertise required for high-quality ultrasound exams, expanding access to diagnostic imaging.
Integration Options
Integrated with Kailo Medical's SonoReview structured reporting software, allowing for seamless incorporation into existing radiology workflows. Through SonoReview, it can be integrated with Electronic Medical Records (EMR), Radiology Information Systems (RIS), Vendor-Neutral Archives (VNA), and Picture Archiving and Communication Systems (PACS). The software is designed to work with both portable and non-portable ultrasound devices. Medo, the developer, was acquired by Exo, suggesting further integration into Exo's ultrasound platform.
Compliance Status
Received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in May 2021, making it one of the first AI tools to simplify thyroid ultrasound scanning workflow to achieve this. The company is actively seeking additional regulatory approvals in Europe, Canada, and other regions globally.
Pricing Model
The company aims to offer its software platform through subscription plans. Specific pricing tiers or details are not publicly disclosed in the available information.
User Experience
Described as providing a 'seamless, fast, and objective workflow' that simplifies the process for both sonographers and radiologists. Clinician feedback indicates it significantly benefits daily workflow, making thyroid ultrasound a 'less frustrating test' due to convenient presentation of measurements and nodule characteristics. It enables simplified thyroid protocols, potentially shortening scan times and improving assessment consistency.
Implementation Complexity
Designed to simplify the acquisition and interpretation of ultrasound images, radically lowering the expertise required for accurate diagnoses. Its integration with existing structured reporting systems like SonoReview is described as seamless, facilitating its adoption into clinical workflows. Pilot testing has been conducted in clinical settings.
Evidence Base
Developed by a University of Alberta spinoff company with contributions from radiologists and researchers. It is one of four FDA-approved Computer-Aided Detection (CAD) systems for thyroid nodule diagnostics. While the company has built multiple FDA-cleared products and has strong partnerships for clinical validation, a systematic review noted a 'lack of extensive external validation of this software in real-world clinical setting' and that it 'requires manual input in the form of ROI to localize nodule' and was 'tested only on Philips, GE, and Siemens ultrasound devices'.
Physician Tip

MEDO-Thyroid can significantly streamline thyroid ultrasound interpretation and reporting, especially for cases with multiple nodules, by automating measurements and TI-RADS characterization. While it simplifies the workflow and can reduce scan times, clinicians should remain aware of the need for manual input for region of interest (ROI) localization and consider the current scope of its external validation. Its ability to cross-reference nodules across multiple planes offers a valuable perspective akin to other advanced imaging modalities.

The integration with Kailo Medical's SonoReview is a key pathway for seamless adoption into existing radiology IT infrastructure, including PACS, RIS, and EMR systems. This allows for efficient data flow and structured reporting within familiar clinical environments. Future integrations may be expected through its acquisition by Exo, potentially expanding its compatibility with a broader range of ultrasound platforms.

Details

Category Endocrinology & Metabolic AI, Radiology & Imaging AI
Pricing Contact for pricing
DeploymentCloud-based
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

MEDO-Thyroid received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on April 23, 2021 (K203502). It is classified as a Class II medical device under Regulation Number 21 CFR 892.2050 (Picture Archiving And Communications System) with Product Code QIH.

Integrations
EHR Not specified
Specialties Endocrinology, Otolaryngology (ENT), Radiology

What the Web Says

MEDO-Thyroid is an AI-powered software solution designed to streamline and enhance the accuracy of thyroid ultrasound examinations. It automates image selection, calculates measurements, and assists in characterizing nodules using the TI-RADS system, ultimately generating individualized interactive reports. The software has received FDA 510(k) clearance and aims to make thyroid ultrasounds faster, easier, and more objective for both patients and clinicians.

Overall: Positive

Strengths

  • Simplifies and speeds up the thyroid ultrasound workflow.
  • Automates optimal image selection and measurement calculations.
  • Assists in locating, measuring, and characterizing thyroid nodules using TI-RADS.
  • Generates individualized, interactive reports.
  • Aims to reduce subjectivity and potential for error in thyroid ultrasound interpretation.
  • Can improve the performance of junior physicians when assisted by AI.

Limitations

  • Not yet in widespread clinical use.
  • Limited information available from independent tech reviewers, G2, Capterra, or Reddit specifically for MEDO-Thyroid.
  • Some AI tools for thyroid nodules have shown limitations in specificity compared to senior physicians, and potential shortfalls in performance with malignant nodules in subgroup analysis.
  • External validity of AI models can be uncertain if solely trained and evaluated on single retrospective datasets.

Based on reviews from: Medimaging.net, HealthAidb, PMC, AuntMinnie, University of Alberta - Folio, AJR Special Series on AI Applications, BioSpace

Last updated: 2026-07-18

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Press & Coverage

AuntMinnie
Medo gets FDA clearance for AI thyroid software | AuntMinnie
Medo received 510(k) clearance from the U.S. FDA for Medo-Thyroid, an AI software that streamlines thyroid ultrasound scanning by automatically reviewing data, selecting optimal images, calculating measurements, and assisting in nodule characterization using TI-RADS.
2021-05
Folio - University of Alberta
AI innovation will make thyroid ultrasounds faster and easier | Folio - University of Alberta
A University of Alberta spinoff company, MEDO.ai, received FDA approval for its MEDO-Thyroid tool, an AI-powered solution designed to make thyroid ultrasounds faster, easier, and more reliable.
2021-05
Medimaging.net
AI Tool Simplifies Thyroid Ultrasound Scanning Workflow - Medimaging.net
Medo's Medo-Thyroid software uses AI and machine learning to simplify thyroid nodule classification by analyzing ultrasound sweeps, selecting relevant images, calculating measurements, and segmenting nodules for TI-RADS scoring.
2021-05
accessdata.fda.gov
MEDO DX Pte. Ltd. April 23, 2021 Dornoosh Zonoobi CEO and Co-founder 4560 TEC Centre, 10230 Jasper Avenue Edmonton, Alberta T5J - accessdata.fda.gov
The FDA's 510(k) summary for MEDO-Thyroid details its classification as automated radiological image processing software, its intended use for viewing and quantifying ultrasound thyroid image data in adults, and its substantial equivalence to predicate devices.
2021-04
MIC Medical Imaging
Medo AI and Medical Imaging Consultants Announce Partnership to Simplify Diagnostic Ultrasound Imaging
Medo AI and Medical Imaging Consultants (MIC) partnered to revolutionize diagnostic imaging, with their first collaboration focusing on simplifying thyroid examinations using Medo-Thyroid to improve patient experience and diagnostic accuracy.
2021-12
HealthImaging
Kailo Medical and Medo AI partner on thyroid ultrasound diagnosis
Kailo Medical integrated Medo Thyroid into its SonoReview product to offer rapid nodule classification and improve thyroid ultrasound efficiency and accuracy.
2021-06
AJR (American Journal of Roentgenology)
Artificial Intelligence (AI) Tools for Thyroid Nodules on Ultrasound, From the AJR Special Series on AI Applications
Medo Thyroid is an FDA-approved AI tool for automatically segmenting both the thyroid and thyroid nodules, showing high concordance with experienced radiologists for measurements.
2022-04
Journal of Clinical Medicine (via NIH PMC)
Role of Artificial Intelligence in Thyroid Cancer Diagnosis - PMC - NIH
MEDO-Thyroid is listed as an FDA-approved AI tool for thyroid nodule diagnosis, utilizing video input and cloud-based processing to aid in the analysis of thyroid ultrasound images.
2025-04

Videos

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Frequently Asked Questions

MEDO-Thyroid is an FDA 510(k) cleared AI-powered software designed to streamline thyroid ultrasound scanning. It uses AI to automatically analyze video sweeps of the thyroid gland, select optimal images, calculate standard measurements for lobes, isthmus, and nodules, and assist in characterizing nodules using the TI-RADS system to generate an interactive report.
MEDO-Thyroid received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in May 2021, making it the world's first AI tool to simplify thyroid ultrasound scanning workflow. As an FDA-cleared medical device, it is expected to adhere to relevant healthcare data protection regulations, though specific details on HIPAA or GDPR compliance were not explicitly found in the provided search results.
While MEDO-Thyroid aims to reduce subjectivity and improve workflow, a systematic review noted limitations for similar AI tools, including a lack of extensive external validation in real-world clinical settings and potential biases if models are trained on data sets from populations with different screening and surgical practices. Physicians should interpret MEDO-Thyroid's preliminary reports as an assistive tool, retaining ultimate clinical judgment, and are free to edit the report if they have a different opinion.
MEDO-Thyroid aims to make thyroid ultrasounds faster, easier, and more objective compared to traditional manual methods, which can be time-consuming and error-prone, especially with multiple nodules. It is one of four FDA-approved AI CADs for thyroid nodules, alongside AmCAD-UT, S-Detect, and Koios DS, all aiming to improve nodule localization and risk stratification.
The search results do not explicitly state the pricing model or specific insurance/reimbursement codes for MEDO-Thyroid. However, as an FDA-cleared medical software, its adoption would likely involve a subscription or per-use fee for healthcare providers, with potential for integration into existing diagnostic imaging reimbursement pathways. The company states it provides both clinical and financial value to stakeholders.
MEDO-Thyroid is designed for seamless integration into clinical workflows. For example, it has integrated with Kailo Medical's SonoReview structured reporting software to streamline nodule classification and report generation, allowing users to benefit from AI assistance and efficiency within their existing systems. The system creates an individualized interactive report with a single click.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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