Clarius Ultrasound

by Clarius Mobile Health  · Based in Canada → — High-Definition Wireless Ultrasound Powered by AI for Every Clinician.
Critical Care Emergency Medicine Radiology
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Clarius ultrasound scanners range from approximately $3,595 to $5,990 usd. a clarius membership is available for $595/year or a $2,500 lifetime fee, which is practically essential for unlocking full functionality, including cloud storage, dicom/pacs integration, and advanced ai features. some niche presets may be sold separately.
Regulatory Status Disclosed

Overview

Clarius Mobile Health is a leading innovator in medical imaging, dedicated to making high-performance, affordable, and easy-to-use ultrasound solutions accessible to medical professionals worldwide. Founded in 2014, Clarius has pioneered wireless handheld ultrasound scanners that connect to iOS and Android devices, delivering high-resolution images traditionally associated with bulkier, high-end systems at a fraction of the cost. The company’s core mission is to empower clinicians across various specialties with immediate access to medical imaging, enhancing diagnostic capabilities and improving patient outcomes.

Clarius ultrasound systems are significantly enhanced by artificial intelligence (AI) capabilities, which automate image optimization, detect anatomy, and provide real-time guidance. This AI integration simplifies complex workflows, making ultrasound more intuitive for both experienced practitioners and novice users. With a growing suite of FDA-cleared AI models for specific applications, Clarius is transforming point-of-care ultrasound (POCUS) through intelligent tools for education, diagnosis, and workflow efficiency.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • High-Definition Wireless Ultrasound Scanners
  • AI-Powered Image Optimization (Auto Preset AI)
  • AI-Guided Anatomy Detection and Labeling (T-Modeu2122)
  • Mobile App for iOS and Android Devices
  • Cloud Storage and Management (Clarius Cloud)
  • DICOM/PACS Integration
  • Real-time Telemedicine (Clarius Live)
  • In-App Tutorials and Educational Resources (Clarius Classroom)
  • Automated Measurements (e.g., OB AI, Bladder AI, Prostate AI, Generic Volume)
  • Specialty-Specific Presets and Workflows

Use Cases

  • Point-of-Care Diagnostics and Procedures
  • Early Detection of Psoriatic Arthritis
  • Prenatal Monitoring and Fetal Biometry
  • Prostate and Bladder Volume Measurement
  • Cardiac and Musculoskeletal Ultrasound Training
  • Nerve Blocks and Aesthetic Procedures

What Physicians Need to Know

DICOM Support & Standards
Clarius supports DICOM Store and DICOM Worklist, enabling transfer of saved images or live data to a DICOM server in various formats. The Clarius app can also download DICOM Worklists to auto-fill patient information.
PACS Integration Method
Exams are sent directly from the smart device to the HIPAA-compliant Clarius Cloud for secure storage and management. Alternatively, it can connect to any DICOM-compliant server.
Reading Room Workflow Impact
Clarius' wireless and portable design enhances mobility for point-of-care use. AI-powered features like 'Auto Preset AI' automatically optimize imaging settings, and 'T-Mode AI' provides real-time anatomical overlays for easier learning and identification. Built-in CPT codes streamline billing, and various AI models automate measurements (e.g., fetal biometry, tendon thickness, bladder volume, prostate volume, median nerve), significantly reducing manual effort and improving efficiency.
AI Model Architecture
Clarius utilizes advanced AI technologies and non-adaptive machine learning algorithms for automated image quality adjustments, anatomy recognition ('Auto Preset AI'), and real-time anatomical overlays ('T-Mode AI'). Specific AI models (e.g., OB AI, MSK AI, Bladder AI, Prostate AI, Median Nerve AI) are trained on extensive datasets (e.g., OB AI on over 30,000 fetal ultrasound images) to perform automated segmentation and measurements.
Processing Speed (per study)
Clarius scanners feature Octal Beamforming technology with eight beamformers, enabling 8x faster data processing and frame rates compared to most handheld scanners. AI-driven measurements, such as bladder volume and tendon segmentation, are often completed in seconds.
FDA Clearance Pathway
Clarius C3 and L7 scanners received 510(k) clearance in 2016. Multiple AI models, including OB AI (June 2024), MSK AI (January 2023), Prostate AI, and Median Nerve AI (2025), have also received 510(k) clearances, bringing the total to 6 FDA-cleared AI models and 16 deployed AI technologies by the end of 2025.
Supported Modalities
Clarius exclusively supports ultrasound (US) imaging. It is designed for a wide range of ultrasound applications including abdominal, cardiac, obstetrics/gynecology, musculoskeletal (MSK), nerve, ocular, vascular, small parts (e.g., thyroid), emergency medicine, critical care, primary care, urology, and women's health. The PAL HD3 scanner combines phased and linear arrays for whole-body ultrasound.
Sensitivity & Specificity Data
Studies indicate Clarius' performance in various applications: a 2020 study showed 65% concordance with cart-based ultrasound for MSK abnormalities. For carpal tunnel syndrome, Clarius measurements closely aligned with conventional systems (mean difference 0.66 mm2, p=0.55). Bladder AI demonstrated excellent reliability (ICC 0.90) compared to human measurements. Prostate volume measurements with Clarius TAUS showed strong correlation (r=0.911, p<0.001) with specimen weight for larger prostates.
Physician Tip

Leverage Clarius' AI-powered 'Auto Preset AI' for rapid image optimization and 'T-Mode AI' for real-time anatomical guidance, especially beneficial for novice users or quick assessments. Utilize the automated measurement tools (e.g., OB AI, MSK AI, Bladder AI) to streamline workflow and reduce manual errors. The portability and wireless nature make it ideal for point-of-care diagnostics, procedural guidance, and patient education directly at the bedside. Integrate with existing DICOM servers or Clarius Cloud for seamless image management and reporting. Keep an eye on new FDA-cleared AI models as Clarius continues to expand its diagnostic and workflow-enhancing capabilities.

Clarius offers robust integration through DICOM Store and Worklist for PACS compatibility. Its proprietary Clarius Cloud provides HIPAA-compliant storage and exam management, accessible from iOS and Android devices. The open software platform and Clarius SDK enable third-party developers to integrate AI-powered solutions, expanding its ecosystem. Built-in CPT codes in the app aid in billing integration.

Details

Category Radiology & Imaging AI
Pricing Clarius ultrasound scanners range from approximately $3,595 to $5,990 usd. a clarius membership is available for $595/year or a $2,500 lifetime fee, which is practically essential for unlocking full functionality, including cloud storage, dicom/pacs integration, and advanced ai features. some niche presets may be sold separately. — Scanners: $3,595-$5,990; Membership: $595/year or $2,500 lifetime; Niche presets sold separately.
DeploymentCloud-connected, Mobile App (iOS/Android)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Clarius has received multiple FDA 510(k) clearances for its ultrasound scanners and various AI models. This includes clearances for Clarius OB AI (fetal biometry measurements), Clarius Bladder AI (bladder volume measurement), Clarius Prostate AI (prostate volume measurement), and MSK AI (automated tendon measurements for patellar, plantar fascia, and Achilles tendons).
Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Radiology

Ratings & Reviews

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Press & Coverage

Clarius Mobile Health (via PR Newswire)
FDA Clears Clarius OB AI for Handheld Ultrasound: A Leap Forward in Prenatal Care
Clarius Mobile Health has received FDA clearance for its Clarius OB AI fetal biometric measurement tool, which aims to improve access to prenatal monitoring and care, especially in resource-limited areas. This AI model automatically performs fetal biometry measurements to estimate fetal age, weight, and growth intervals.
2024-06
Imaging Technology News
Clarius and Echo Mind Ai Join Forces to Help Diagnose MSK Ailments Faster Using Handheld Ultrasound and Tele-Sonography
Clarius Mobile Health and Echo Mind Ai have partnered to offer an integrated solution that empowers physiotherapists and sports medicine physicians to use point-of-care ultrasound for faster diagnosis and treatment of musculoskeletal ailments. This collaboration aims to make ultrasound technology more accessible and efficient.
2023-08
Diagnostic and Interventional Cardiology (DAIC)
Clarius Introduces New Ultrasound Software Tools to Enhance Efficiency, User Experience
Clarius Mobile Health has announced new ultrasound innovations, including enterprise software for managing multiple scanners, AI-powered capabilities, and built-in CPT medical codes to assist with billing and reimbursement. These features are designed to improve workflow, streamline billing, and make handheld ultrasound easier to learn and use.
2025-01
PR Newswire
Clarius Mobile Health Announces Historic 2025: Achieves Profitability, Double-Digit Growth, and New FDA Clearances for Ultrasound AI
Clarius Mobile Health reported a historic 2025, achieving profitability, double-digit growth, and new FDA clearances for its ultrasound AI models. The company introduced two new FDA-cleared AI models, bringing the total to six, and expanded its T-Modeu2122 capabilities and educational partnerships.
2025-12
Fierce Biotech
Clarius tacks on European nod for whole-body hand-held ultrasound scanner
Clarius Mobile Health has received European Union and UK clearance for its Clarius PAL HD3 scanner, a dual-array handheld ultrasound device for whole-body imaging. This follows its FDA clearance and debut in Australia, expanding its global reach.
2024-01
PR Newswire
Clarius Unveils T-Modeu2122 Heart: New AI-Powered Training Tool Empowers Primary Care Physicians to Perform Cardiac Ultrasound Exams
Clarius Mobile Health has launched T-Modeu2122 Heart, an AI-powered training technology designed to help primary care physicians, medical students, and emergency clinicians master point-of-care cardiac ultrasound. This tool simplifies complex cardiac anatomy through real-time AI labeling.
2026-03
AuntMinnie.com
FDA Clears Clarius' AI ultrasound app - AuntMinnie
Clarius Mobile Health has received FDA 510(k) clearance for its artificial intelligence (AI) application for musculoskeletal imaging. This AI model helps new users learn ultrasound and speeds up the diagnosis of musculoskeletal injuries by automatically identifying, highlighting, and measuring tendon structures.
2023-02
Diagnostic and Interventional Cardiology (DAIC)
Clarius Disrupts Medical Ultrasound Market with 10 New Ultra-Portable Wireless Scanners for Apple and Android Devices
Clarius Mobile Health introduced a third-generation product line of 10 high-performance handheld wireless ultrasound scanners for various medical specialties. These new pocket-sized scanners are significantly smaller and lighter, offering advanced features and AI to optimize imaging for ease of use.
2022-02

Videos

Product demos, reviews, and walkthroughs for Clarius Ultrasound.

View all on YouTube

Frequently Asked Questions

Clarius Ultrasound leverages AI through features like Auto Preset AI for automatic image optimization and T-Mode AI for real-time anatomical overlays, which help in identifying structures. It also offers specialized AI models for tasks such as fetal biometry (OB AI), prostate volume measurement (Prostate AI), bladder volume assessment, and musculoskeletal imaging, aiming to streamline workflows and reduce the learning curve for users.
Clarius Ultrasound has secured FDA 510(k) clearance for several of its AI applications, including OB AI, Prostate AI, Bladder AI, and MSK AI. The Clarius Cloud, which handles image management and storage, is HIPAA-compliant and uses encrypted HTTPS for data uploads, with patient data automatically anonymized for AI training.
Clarius handheld scanners are known for providing high-resolution imaging comparable to traditional cart-based systems, often at a more affordable price point. While some competitors offer all-in-one probes, Clarius's piezoelectric crystal technology generally delivers superior image resolution and deeper penetration, particularly beneficial for specialties requiring high detail like MSK or vascular imaging.
Clarius HD3 scanners typically range from $2,995 to $5,990 USD, with an annual membership costing approximately $595 USD. Although presented as optional, this membership is often essential for accessing advanced features like Doppler modes, cloud storage, PDF report export, and most AI functionalities.
Clarius AI is designed to assist and inform clinical management, but it is not intended to replace a physician's clinical judgment, who retains ultimate responsibility for diagnoses. While AI features like T-Mode are expanding, their current availability might be limited to specific applications such as aesthetics, plastic surgery, and rotator cuff imaging.
Clarius ensures patient data security and privacy through its HIPAA-compliant Clarius Cloud, which encrypts data uploads via HTTPS. Patient information is automatically anonymized when used for AI algorithm training and labeling. Access to data is strictly controlled, with clinicians only able to view their own patient exams, while institution administrators have broader access.

Compare Clarius Ultrasound

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Clarius AI is a suite of artificial intelligence features integrated into Clarius Mobile Health's handheld ultrasound scanners and app, designed to enhance image quality, automate measurements, and provide real-time guidance for clinicians across various specialties.
Subscription-based with scanner purchase or one-time purchase with add-ons.
Clarius Bladder AI
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Clarius Bladder AI is a non-invasive, AI-powered tool that automatically and accurately measures bladder volume in seconds using Clarius HD3 wireless handheld ultrasound scanners, providing real-time feedback to clinicians.
Clarius bladder ai is included with the advanced primary / critical care package, which is part of the clarius membership. clarius hd3 scanners start at $2,995 usd with an annual membership of $595 usd, or can be purchased as a one-time payment starting at $4,900 usd. the membership is essential for accessing advanced software features, including ai tools and cloud management.
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Clarius Ejection Fraction AI is an AI-powered ultrasound tool for automated left ventricular ejection fraction calculation, integrated into the Clarius Ultrasound App for real-time cardiac assessments.
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Clarius Median Nerve AI
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Clarius Median Nerve AI is an FDA-cleared, AI-powered tool within the Clarius Ultrasound App that assists clinicians in real-time localization and measurement of the median nerve for Carpal Tunnel Syndrome assessments using handheld ultrasound scanners.
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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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