Clarius Median Nerve AI

by Clarius Mobile Health  · Based in Canada →Making medical imaging accessible everywhere with AI-powered ultrasound.
Neurology Orthopedics Radiology

Subscription-based for ai features; requires purchase of clarius hd3 scanner.
Regulatory Status Disclosed

Overview

The Clarius Median Nerve AI is an advanced artificial intelligence tool integrated within the Clarius Ultrasound App, designed to assist clinicians in the assessment of Carpal Tunnel Syndrome (CTS). It works in conjunction with Clarius HD3 handheld wireless ultrasound scanners, which connect to iOS and Android devices. The AI technology automatically identifies and segments the median nerve in real-time ultrasound images, providing accurate cross-sectional area measurements. This feature aims to enhance diagnostic accuracy and efficiency, reduce reliance on manual interpretation, and streamline the diagnostic process for CTS. Clarius Mobile Health’s overarching mission is to provide accurate, easy-to-use, and affordable ultrasound tools to medical professionals across various specialties, improving patient care globally.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered median nerve segmentation in real-time
  • Automated cross-sectional area (CSA) measurement
  • Integration with Clarius HD3 handheld ultrasound scanners
  • Compatible with iOS and Android devices via Clarius App
  • Enhances diagnostic accuracy and efficiency for Carpal Tunnel Syndrome
  • Quality indicator for accurate measurements during scanning
  • Adjustable segmentation and calipers for user control
  • Image saving and reporting capabilities
  • Part of the Clarius Intelligence suite of AI tools
  • Real-time imaging for immediate assessment

Use Cases

  • Diagnosis of Carpal Tunnel Syndrome (CTS)
  • Assessment of median nerve pathology
  • Guidance for treatment and follow-up of CTS
  • Point-of-care ultrasound (POCUS) for hand and wrist conditions

What Physicians Need to Know

Median Nerve Localization & Measurement
Clarius Median Nerve AI helps to automatically locate and measure the median nerve, including its cross-sectional area, during Carpal Tunnel Syndrome (CTS) assessments. This automation reduces reliance on manual interpretation, which can be subjective and time-consuming, thereby improving diagnostic precision and efficiency.
Workflow Efficiency
The AI model automates the identification and outlining (segmentation) of the median nerve in ultrasound images, making the process faster and more efficient. It performs cross-sectional area measurements quickly once the image is frozen, with the ability to adjust segmentation and calipers as needed.
Mobile App Integration
Clarius AI-powered handheld wireless ultrasound scanners connect to iOS and Android devices, delivering high-resolution ultrasound images through the Clarius App. The AI models, including Median Nerve AI, are available within the Clarius ultrasound App.
Physician Tip

Clarius Median Nerve AI streamlines Carpal Tunnel Syndrome (CTS) assessments by providing rapid and accurate median nerve localization and measurement. This can significantly enhance workflow efficiency and diagnostic confidence, especially for clinicians performing point-of-care ultrasound. The tool also serves as a valuable aid for training less experienced clinicians in identifying and measuring the median nerve. Users retain the ability to manually adjust measurements, ensuring clinical oversight and judgment.

Clarius Median Nerve AI is integrated directly into the Clarius ultrasound App, which operates on iOS and Android smart devices. It is part of the broader Clarius AI portfolio, designed to work seamlessly with Clarius handheld wireless ultrasound scanners.

Details

Category Neurology AI, Radiology & Imaging AI
Pricing Subscription-based for ai features; requires purchase of clarius hd3 scanner.
  • Scanners start at $2,995 USD with $595/year annual membership; or one-time purchase from $4,900 USD with add-ons; Membership unlocks AI tools, advanced software, unlimited cloud, telemedicine, DICOM/PACS integration
DeploymentMobile app (iOS/Android) connected to wireless handheld scanners; cloud-based for data management.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

Clarius Median Nerve AI received FDA clearance (K250226) on May 8, 2025, to help locate and measure the median nerve during Carpal Tunnel Syndrome assessments.

Integrations
EHR Not specified
Specialties Neurology, Orthopedics, Radiology

What the Web Says

Clarius Median Nerve AI is an AI-powered tool integrated into Clarius handheld ultrasound devices, designed to automate median nerve measurements for rapid and accurate diagnosis of carpal tunnel syndrome (CTS). It received FDA clearance on May 8, 2025, and is available with Clarius L20 HD3, L15 HD3, and L7 HD3 handheld ultrasound scanners. The tool aims to improve diagnostic accuracy, streamline workflows, and reduce variability in CTS diagnosis.

Overall: Positive

Strengths

  • Automated median nerve identification and measurement, improving workflow and efficiency.
  • Accelerated and accurate diagnosis of carpal tunnel syndrome (CTS).
  • Enhanced diagnostic confidence for healthcare professionals.
  • User-friendly interface and easy to learn, especially for new ultrasound users.
  • High-resolution image quality comparable to compact systems at a fraction of the cost.
  • Portable and wireless design, allowing for greater flexibility and accessibility in various clinical settings.

Limitations

  • Some users have reported issues with poor wireless connection and slower frame rates, particularly with Android devices.
  • The handheld devices can be heavier and larger than conventional probes, potentially leading to discomfort during prolonged use.
  • Initial versions of Clarius handheld devices had average image quality and issues with overheating.
  • The accuracy of ultrasound can be influenced by operator experience and equipment variability, even with AI assistance.
  • The device's wider footprint, while advantageous for deeper structures, can make cardiac scanning more challenging.

Based on reviews from: HealthAidb, FDA Radiology AI Device - X-ray Interpreter, PR Newswire, Imaging Technology News, Sunil Manjila MD, Peachtree POCUS (YouTube), Sports Medicine Ultrasound Group, Clarius Mobile Health (YouTube), Reddit, The Medical Futurist

Last updated: 2026-07-17

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Press & Coverage

X-ray Interpreter
Clarius Median Nerve AI | FDA Radiology AI Device - X-ray Interpreter
Clarius Median Nerve AI is a machine learning-based software integrated with the Clarius Ultrasound Scanner system that automatically segments the median nerve and measures its cross-sectional area in ultrasound images, assisting healthcare professionals in musculoskeletal ultrasound imaging. It received FDA approval on May 8, 2025.
2025-05
PR Newswire
Clarius Mobile Health Announces Historic 2025: Achieves Profitability, Double-Digit Growth, and New FDA Clearances for Ultrasound AI - PR Newswire
Clarius Mobile Health announced a record year in 2025, achieving profitability and 20% growth, driven by the introduction of new FDA-cleared AI models, including Clarius Median Nerve AI for Carpal Tunnel Syndrome assessments. The company now has sixteen AI models deployed across various applications.
2025-12
FirstWord HealthTech
FDA Clears New Clarius Median Nerve AI Tool to Help Physicians Quickly Diagnose Carpal Tunnel Syndrome. - FirstWord HealthTech
The FDA cleared the new Clarius Median Nerve AI tool to assist physicians in quickly diagnosing Carpal Tunnel Syndrome. This announcement was made on May 27, 2025.
2025-05
Innolitics
Weekly AI/ML 510(k)s, De Novos, and BDDs for December 14 to 20 - Innolitics
Clarius Median Nerve AI was among the AI/ML software 510(k) clearances granted by the FDA in December 2025, specifically on December 17, 2025. This tool helps locate and measure the median nerve during Carpal Tunnel Syndrome assessments using ultrasound images.
2025-12
FDA
K250226 - 510(k) Premarket Notification - FDA
This is the official FDA 510(k) Premarket Notification for Clarius Median Nerve AI, submitted by Clarius Mobile Health Corp. The document details the regulatory information for the device, which was cleared on May 8, 2025.
2025-05
Aletia Index
Clarius Median Nerve AI | Clarius Mobile Health Corp. - Aletia Index
Aletia Index provides an overview of Clarius Median Nerve AI, including its regulatory clearance status across the FDA and clinical assurance data. It notes that some fields are incomplete or unverified, inviting Clarius Mobile Health Corp. to update the listing.
unknown
Therapeutic Goods Administration (TGA)
AI-enabled medical devices in the ARTG - Therapeutic Goods Administration (TGA)
The Therapeutic Goods Administration (TGA) in Australia lists Clarius Median Nerve AI as an AI-enabled medical device, intended for segmentation and semi-automatic non-invasive measurements of the median nerve cross-sectional area on ultrasound data. It specifies that the user must be a healthcare professional trained and qualified in ultrasound, and the device is for adult patients only.
2026-04
LeadIQ
Clarius Mobile Health Corp. launched AI tool that automates median nerve measurements on May 27th '25. - LeadIQ
Clarius Mobile Health Corp. launched an AI tool that automates median nerve measurements on May 27, 2025, to accelerate and standardize the diagnosis of carpal tunnel syndrome (CTS). This tool, Clarius Median Nerve AI, is available with specific Clarius handheld ultrasound scanners.
2025-05

Videos

Product demos, reviews, and walkthroughs for Clarius Median Nerve AI.

View all on YouTube

Frequently Asked Questions

The Clarius Median Nerve AI semi-automatically identifies and measures the median nerve in real-time ultrasound images, providing a transparent overlay and placing calipers for thickness measurements. This functionality is designed to streamline the assessment process for carpal tunnel syndrome, potentially enhancing workflow efficiency and boosting diagnostic confidence.
The Clarius Median Nerve AI received FDA 510(k) clearance in 2025, classifying it as a Class II medical device. While it is an assistive tool, physicians retain ultimate responsibility for clinical decision-making and confirming measurements based on their professional judgment and standard practices.
While verification testing indicated that Clarius AI auto-measurements were non-inferior to manual measurements by expert clinicians, it remains an assistive tool and does not replace comprehensive clinical judgment. Its accuracy can be influenced by operator experience and equipment variability, and it may not detect proximal causes of symptoms or false negatives in early carpal tunnel syndrome stages.
Clarius Median Nerve AI aims to standardize and automate measurements, with studies indicating that AI models can achieve high sensitivity and specificity in diagnosing carpal tunnel syndrome, potentially enhancing traditional manual ultrasound. Other diagnostic modalities include nerve conduction studies (NCS) and MRI, though AI in ultrasound offers advantages in cost and real-time assessment.
The Clarius Median Nerve AI is typically available as an advanced software feature, often requiring a Clarius Membership, which is an annual subscription for general advanced features and cloud management. The Median Nerve AI itself is listed as a one-time purchase option for $2,500.00, which can also be paid through monthly installments.
The Clarius Median Nerve AI is integrated within the Clarius App, which operates on iOS and Android devices and connects to the Clarius Cloud for exam management. While direct EMR integration specifics for this particular AI are not explicitly detailed, the Clarius ecosystem supports cloud-based exam management and offers in-app tutorials to assist with the learning curve.
Physicians retain the ultimate responsibility for ascertaining measurements and making clinical decisions, as the Clarius Median Nerve AI functions as an assistive tool and is not intended to replace clinical judgment. Users must be trained and qualified in musculoskeletal ultrasound to ensure proper interpretation and application of the AI's output.

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