Clarius Ultrasound Scanner

by Clarius Mobile Health Corp.  · Based in Canada → — Making high-performance, affordable, and easy-to-use AI-powered medical imaging accessible everywhere.
Anesthesiology Cardiology Emergency Medicine
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Paid
Documentation ProvidedRegulatory Status Disclosed

Overview

The Clarius Ultrasound Scanner represents a significant advancement in point-of-care ultrasound (POCUS) technology, offering physicians a high-definition, AI-powered, and wireless imaging solution. Designed to be as portable as a smartphone, Clarius scanners connect seamlessly to iOS and Android devices, transforming them into powerful ultrasound systems. This eliminates the need for bulky, expensive cart-based machines, making advanced diagnostic imaging readily available in diverse clinical settings, from primary care offices to emergency rooms and remote locations.

Clarius scanners are engineered with advanced imaging capabilities, including 192 piezoelectric crystals and 8 beamformers, which deliver image quality comparable to higher-end traditional systems. The integration of artificial intelligence, referred to as Clarius Intelligence, simplifies image acquisition and interpretation. Features like Auto Preset AI automatically optimize settings for the scanned area, while specialized AI models assist with automated measurements for various applications, such as fetal biometry (Clarius OB AI) and prostate volume (Clarius Prostate AI). This AI-driven approach aims to reduce the learning curve for new ultrasound users and enhance diagnostic confidence for experienced practitioners.

The Clarius ecosystem extends beyond the hardware, offering a comprehensive software-as-a-service (SaaS) platform. The Clarius App provides intuitive controls, real-time imaging, and advanced workflow features like color/power Doppler, spatial compounding, and needle enhancement. The secure Clarius Cloud offers unlimited storage for exams, facilitates exam management, and generates PDF reports, with DICOM integration for seamless PACS connectivity. Furthermore, the Clarius Marketplace and SDK enable integration with third-party AI innovations and telemedicine services, expanding the utility and collaborative potential of the platform.

With a range of specialized transducers, Clarius supports a broad spectrum of medical specialties including primary care, emergency medicine, critical care, obstetrics, gynecology, urology, musculoskeletal (MSK), aesthetics, and cardiology. The durable, water-submersible design and long-lasting rechargeable batteries ensure reliability in demanding environments, with accessories like the Power Fan HD3 enabling continuous, all-day scanning. Clarius is committed to improving patient outcomes by making high-quality ultrasound technology more accessible and user-friendly for clinicians worldwide.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Wireless, handheld design
  • AI-powered image optimization and automated measurements
  • High-definition imaging (192 piezoelectric crystals, 8 beamformers)
  • iOS and Android app compatibility
  • Multiple transducer types (linear, curved, phased, endocavity)
  • Color/Power Doppler, Spatial Compounding, Needle Enhancement
  • Clarius Cloud for unlimited storage, exam management, and PDF reports
  • DICOM/PACS integration
  • Real-time guidance and educational tools (T-Mode AI, HeartFocus, ThinkSono AI)
  • Water submersible and durable magnesium case

Use Cases

  • Point-of-care diagnostics and assessments
  • Procedural guidance (e.g., injections, biopsies)
  • Emergency and critical care imaging (e.g., eFAST, cardiac, lung)
  • Obstetrical and gynecological monitoring (e.g., fetal biometry)
  • Musculoskeletal (MSK) assessment and sports medicine
  • Urology (e.g., prostate volume, bladder volume)

What Physicians Need to Know

Evidence Base
Clarius scanners are FDA-cleared and Health Canada approved, and are used in clinical trials and research. The Clarius App includes features like a 12-field lung assessment with scoring (0-3 with cumulative total) to support clinical decision-making at the point of care. Clarius is also actively collaborating with pharmaceutical companies and Contract Research Organizations (CROs) to validate handheld ultrasound as a tool for evidence-based innovation in drug development and patient care.
Clinical Validation Studies
Ongoing studies are validating Clarius handheld ultrasound devices against gold-standard equipment for detecting characteristics of healthy and rheumatic joints in Psoriatic Arthritis patients. A study comparing Clarius to cart-based ultrasound for carpal tunnel syndrome diagnosis found comparable median nerve cross-sectional area (CSA) measurements, with substantial agreement between devices. Clarius has also received FDA clearances for AI models such as Prostate AI and Median Nerve AI.
Differential Diagnosis Support
Clarius offers AI-powered features that assist in diagnosis by automatically identifying, measuring, and labeling anatomical structures in real-time. Examples include MSK AI for key anatomical structures, OB AI for fetal measurements, Bladder AI for bladder volume, Prostate AI for prostate volume calculation, and Median Nerve AI for carpal tunnel syndrome assessments. T-Mode provides AI-powered colored and textured anatomical overlays to enhance learning and identification in areas like the rotator cuff and anterior knee. The Clarius App's 12-field lung assessment also supports clinical decision-making. The Clarius Marketplace further expands this by integrating third-party AI solutions for faster diagnoses.
Clinical Workflow Integration
Clarius scanners are wireless, app-based, and connect to iOS and Android devices, offering portability and flexibility for point-of-care use across various specialties. Features like Auto Preset AI automatically adjust settings for optimal imaging, and Voice Controls enable hands-free operation, streamlining procedures. The Clarius App 12.0 includes built-in CPT medical codes to assist with billing and reimbursement. The Clarius Cloud facilitates exam management and reporting, while the Clarius Marketplace enables integration with third-party AI solutions and tele-sonography services (e.g., Echo Mind Ai for MSK over-reads). The Clarius Power Fan HD3 accessory allows for continuous, all-day scanning without interruption.
Physician Tip

Leverage Clarius's AI-powered features like Auto Preset AI, MSK AI, OB AI, Prostate AI, Median Nerve AI, and T-Mode for rapid image optimization, anatomical identification, and automated measurements to enhance diagnostic confidence and efficiency at the point of care. Utilize the scanner's portability and wireless connectivity for flexible use in diverse clinical settings and for procedural guidance. Explore the Clarius Marketplace for specialized AI tools and tele-sonography services to further augment diagnostic capabilities and streamline reporting. The integrated CPT codes can simplify billing workflows.

Clarius offers an open-source platform with a Software Development Kit (SDK) and a Clarius Marketplace, enabling seamless integration with a growing ecosystem of third-party AI-powered software solutions and tele-sonography services. This allows for expanded clinical utility, specialized diagnostic support, and enhanced workflow automation. The Clarius App itself integrates with both iOS and Android smart devices.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Paid
  • Scanners range from $3,595–$5,990; Clarius Membership is $595/year or $2,500 lifetime (practically essential for full functionality); Some niche presets (e.g., Aesthetics, MSK) are sold separately
DeploymentHybrid
Mobile AppBoth
API Available Yes
Data Export Yes
LanguagesEnglish
Training Yes
Target SizeSolo to large health systems
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated

K232704 (Clarius PAL HD3), K232257 (Clarius Prostate AI), K213436 (Clarius L15 HD3), K192107 (Clarius Ultrasound Scanner).
Integrations
EHR Not specified
Specialties Anesthesiology, Cardiology, Emergency Medicine, Gastroenterology, Nuclear Medicine, Obstetrics & Gynecology, Ophthalmology, Orthopedics, Urology

Social Proof

CustomersOver 35,000 clinicians in more than 70 countries; almost 7 million scans performed.

Support & Reliability

Training Provided Yes

What the Web Says

The Clarius Ultrasound Scanner is a portable, wireless device that has generally received positive reviews from physicians and tech reviewers, particularly for its image quality and portability. It is often compared favorably to other handheld ultrasound devices like the Butterfly iQ and Lumify, especially regarding image resolution. The device is praised for its ease of use, intuitive app, and suitability for various medical applications, including emergency medicine, obstetrics, and musculoskeletal imaging. While earlier versions had some issues with overheating and bulkiness, newer models have addressed these concerns, offering a lighter and more comfortable design.

Overall: Positive

Strengths

  • Good image quality, often comparable to cart-based systems and superior to some other handheld devices.
  • Wireless and highly portable, making it convenient for various settings like field use, home visits, and emergency rooms.
  • Intuitive Clarius App with easy on-screen image controls, excellent for teaching and efficient scanning.
  • Durable and waterproof design (without battery).
  • Removable battery design with appropriate scan time for field settings (earlier models) and good battery life in newer versions.
  • Unlimited cloud storage for scans and compatibility with both iOS and Android devices.

Limitations

  • Earlier versions were prone to overheating, though this has improved in newer models.
  • Can be heavier and bulkier than conventional probes due to housing the battery and technology, though newer versions are lighter.
  • Wireless connection can sometimes be poor, leading to slower frame rates or delays in connecting.
  • Difficulty sterilizing the device.
  • Some users found the image resolution for deeper structures to be less optimal compared to superficial structures.
  • Price and additional add-ons, including an annual subscription, can be a relative con for some users.

Based on reviews from: Emergency Physicians Monthly, The Medical Futurist, TodoPocus, Bastion Inc., Sports Medicine Ultrasound Group, Reddit, YouTube, Clarius Ultrasound App - Ratings & Reviews, Critical Care Northampton, The Healthcare Guys

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

Medical Dialogues
FDA Clears AI-Powered Ejection Fraction Calculator for Clarius Ultrasound Scanner App
The FDA has cleared an automated ejection fraction (EF) calculator for the Clarius wireless ultrasound scanner app, enabling real-time, AI-assisted assessment of cardiac function. This technology provides objective and rapid measurement of ejection fraction, aiding primary care and emergency physicians in making faster and more accurate bedside cardiac evaluations.
2026-06
PR Newswire
Clarius and ThinkSono Introduce a New AI-Guided Ultrasound System Enabling Rapid Assessments of DVTs
Clarius Mobile Health and ThinkSono have launched a new AI-guided ultrasound system in Europe to improve the efficiency of detecting deep vein thrombosis (DVT). The ThinkSono Guidance AI App, which pairs with Clarius ultrasound scanners, recently received Class IIb CE mark regulatory approval.
2024-04
PR Newswire
New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems
Clarius Mobile Health introduced Voice Controls, a new AI-powered feature that allows clinicians to control multiple imaging functions with voice commands, freeing their hands for procedures and exams. This feature is available to all Clarius members using any Clarius HD3 wireless ultrasound scanner with the latest app update.
2023-05
PMC - NIH (Obstetrics and Gynecology)
Virtual Compared With In-Clinic Transvaginal Ultrasonography for Ovarian Reserve Assessment
A study published in Obstetrics and Gynecology utilized the Clarius Ultrasound Scanner (K192107) for virtual transvaginal ultrasonography for ovarian reserve assessment. The cordless, wireless, application-based system, with existing FDA clearance for in-clinic use, was employed in a trial where participants performed self-administered virtual exams with telemedicine guidance.
2022-03
PR Newswire
Clarius Simplifies Ultrasound Telemedicine with Latest Release
Clarius Mobile Health released Clarius Live, a telemedicine solution that allows medical professionals to broadcast real-time, live ultrasound imaging to any standard web browser. This feature is integrated into the Clarius app and enables users to request real-time assistance during an ultrasound exam.
2019-05
Vancouver Sun
Vancouver company unveils latest handheld ultrasound scanners
Clarius Mobile Health unveiled its second generation of handheld ultrasound scanners, significantly reducing their size and improving image quality to rival more expensive traditional systems. These portable, AI-driven devices are designed to make ultrasounds more accessible and affordable for medical professionals in various settings.
2019-11
Smithsonian Magazine
This Handheld Ultrasound Scanner Could Be the Next Stethoscope
Clarius, founded in 2014, developed a handheld ultrasound scanner that connects wirelessly to a smartphone app, providing high-quality imaging of the chest and abdomen. The U.S. FDA approved the Clarius ultrasound scanner for use in December 2016, with Health Canada following in January 2017.
2017-01
DAIC
Clarius Mobile Health Debuts Wireless, Handheld Ultrasound for iOS and Android
Clarius Mobile Health showcased a new wireless, handheld ultrasound scanner with a mobile application for iOS and Android smart devices at the American Institute of Ultrasound in Medicine Conference. This compact device is designed for quick exams and guiding procedures, aiming to overcome the price barrier of traditional ultrasound systems.
2016-03

Videos

Product demos, reviews, and walkthroughs for Clarius Ultrasound Scanner.

View all on YouTube

Frequently Asked Questions

Clarius Ultrasound Scanners are designed for point-of-care ultrasound (POCUS), offering high-definition imaging for a wide range of specialties including musculoskeletal, abdominal, cardiac, obstetrics, pain management, and aesthetic procedures. Their wireless, pocket-sized design integrates seamlessly with iOS and Android devices, enhancing portability and efficiency in various clinical settings. The system also incorporates AI-powered features like Auto Preset AI, T-Mode for real-time guidance, and specialized AI models for OB, MSK, and bladder volume, which streamline workflows and aid in image optimization.
Yes, Clarius Ultrasound Scanners have received U.S. Food and Drug Administration (FDA) 510(k) clearance, confirming their substantial equivalence to already marketed devices in terms of safety and effectiveness. Additionally, Clarius devices are CE marked, indicating compliance with European Union regulatory requirements. These clearances ensure the devices meet rigorous safety and performance standards for clinical use.
Clarius scanners are noted for miniaturizing the performance of traditional cart-based systems into a portable, wireless form factor, often at a fraction of the cost. When compared to other handheld devices like GE Vscan Air or Philips Lumify, Clarius is often highlighted for its image quality, particularly for superficial structures, and its integrated cloud ecosystem. However, some comparative studies suggest other handhelds like Vscan Air, Lumify, and Mindray TE Air may offer comparable or superior image quality and ease of use in specific applications.
Clarius HD3 scanners typically start from $2,995 to $5,990 USD, depending on the specific probe model. While a membership is marketed as optional, it is often considered practically essential for unlocking core functionalities such as Doppler modes, cloud storage, AI features, and the ability to save exams, costing $595 USD annually. A one-time purchase option for the scanner is available at a higher upfront cost, with specialized software packages or presets potentially incurring additional fees.
Common limitations include a battery life of approximately one hour of continuous use, requiring about 90 minutes for recharging, which can impact high-volume practices. The device may also experience warming with prolonged scanning sessions, with a recommended maximum of 20 minutes to prevent overheating. While offering good image quality, some users note a potential loss of spatial resolution beyond 4 cm compared to high-end cart-based systems.
Yes, Clarius offers several features to support clinical decision-making and streamline billing. The Clarius App 12.0 includes built-in CPT medical codes for musculoskeletal, urology, and women's health exams to assist with billing and reimbursement. For decision support, it provides a 12-field lung assessment with scoring to evaluate lung health and offers AI-powered T-Mode for real-time anatomical overlays to enhance learning and image interpretation.
Clarius offers a portfolio of specialized wireless ultrasound scanners, each optimized for specific clinical needs across various specialties. For instance, there are linear probes for superficial imaging, convex probes for deeper structures like the abdomen, and phased array probes for cardiac assessments. Some models, like the Clarius PAL HD3, feature dual arrays (phased and linear) in a single transducer, allowing physicians to switch between different scanning modes for comprehensive examinations without needing multiple devices.

Compare Clarius Ultrasound Scanner

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Butterfly iQ3 Ultrasound System vs Clarius Ultrasound Scanner
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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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