Clarius Announces the First FDA-Cleared AI Ultrasound Application for Musculoskeletal Imaging

New Clarius MSK AI model automatically identifies, highlights, and measures tendon structures in the foot, ankle, and knee, accelerating ultrasound mastery for new users and hastening diagnosis and treatment of musculoskeletal injuries.

Clarius Mobile Health, a leading provider of high-definition handheld ultrasound systems, receives 510(k) clearance for its new MSK AI model, which automatically identifies and measures tendons in the foot, ankle, and knee using artificial intelligence (AI). The new MSK AI model will be available soon with the Clarius L7 HD3 and Clarius L15 HD3 high-frequency, wireless handheld ultrasound scanners.

“Ultrasound imaging has long been recognized by the medical community as the best way to see inside the body in real time but learning to detect and recognize anatomy comes with a learning curve,” explains Clarius President and CEO Ohad Arazi. “AI automation is the new frontier and we’re excited to be the world’s first to receive FDA clearance to use AI for musculoskeletal ultrasound. This application will blow the doors open for physiotherapists and orthopedic clinicians to use ultrasound to deliver faster patient care.”

With the Clarius HD3 line of handheld ultrasound scanners introduced last year, high-definition ultrasound imaging has reached unprecedented levels of affordability and usability. Available starting at 3,395 USD with 595 annual membership, Clarius high-definition scanners are now used worldwide as a more affordable and easier-to-use alternative to traditional compact ultrasound systems.

Dr. Alan Hirahara, an Orthopedic Surgeon and sports medicine expert who has been using ultrasound for more than 20 years, is an early tester of the Clarius MSK AI model.

“The new AI from Clarius Mobile Healthcare is a ground-breaking technology that will help with the education of new users to identify MSK structures,” he says. “The technology will also help current users standardize how structures are measured. In research, interobserver variability exists for any measurement of structures. With the AI standardization of measurements, interobserver reliability problems will now be non-existent. I am excited to see where this technology will go as Clarius continues to innovate.”

Clarius has numerous AI automation projects on its product roadmap according to Clarius VP of R&D Kris Dickie. “The company’s app-based ultrasound platform has captured millions of anonymous ultrasound images that enable the development of highly reliable AI models for all parts of the body. We’re also collaborating with more than 10 partners working on AI innovation using our open software platform and software development kit. Additional third-party innovations will soon be available through Clarius Marketplace.”

The Clarius MSK AI model is designed to streamline workflows, inform clinical management, and provide training assistance during musculoskeletal scanning for specific anatomical sites, which include: the plantar fascia (foot), Achilles tendon (ankle), and patellar tendon (knee). The AI analyzes ultrasound imaging in real time and displays a transparent color overlay to identify the tendon in view. Upon pausing the image, the AI labels the tendon and determines the greatest thickness, automatically placing measurement calipers that correspond to the top and bottom of the tendon at its thickest region. The user may alter the measurement calipers to make any necessary adjustments to support clinical decision-making.

“AI isn’t here to replace the ultimate decision by a clinician and it’s commendable that the FDA recognizes the value of AI for optimizing ultrasound image acquisition,” Arazi adds. “If you’ve ever had an ultrasound image taken, you know it takes a very high degree of proficiency. What’s really exciting about AI and ultrasound is that it’s now enabling less proficient healthcare practitioners to acquire quality images to make meaningful clinical decisions quickly.”

Clarius Mobile Health

Clarius is on a mission to make accurate, easy-to-use, and affordable ultrasound tools available to all medical professionals in every specialty. With decades of experience in medical imaging, the team knows that great ultrasound imaging improves confidence and patient care. Today, Clarius handheld wireless ultrasound scanners connect to iOS and Android devices, delivering high-resolution ultrasound images traditionally only available with bulkier, high-end systems at a fraction of the cost.

Three million high-definition scans have been performed using Clarius wireless handheld scanners. Clarius scanners are available in over 90 countries worldwide. Learn more at

Source: Clarius

About Peter Coffaro 504 Articles
Peter Coffaro is a growth-driven and strategic executive with over 25 years of progressive management success in the medical device industry. With a proven track record and recognized expertise, Peter has established himself as one of the top influencers in medical sales, as acknowledged by prestigious publications such as the World Journal of Orthopedics, Exponential Healthtech, and Throughout his career, Peter has accumulated 10 years of combined sales management experience, excelling in various roles including Director, General Manager, Distributor, and Vice President. He has worked for industry-leading orthopedic companies such as Zimmer, DePuy, and Stryker, solidifying his deep knowledge and network within the field. Peter’s passion for innovation and emerging technologies led him to found OrthoFeed, an award-winning blog covering digital orthopedic news and emerging medical technologies. Through this platform, he stays at the forefront of the industry and contributes to the dissemination of valuable insights. Peter is a three-time Hall of Fame award winner at Johnson and Johnson, demonstrating his exceptional contributions and impact on the organization. His expertise extends to areas such as organizational development, business development, sales management, digital marketing, and professional education. Peter earned a B.S. degree in Biology and Chemistry from Northern Illinois University, further complementing his comprehensive understanding of the medical field. With his wealth of experience, strategic mindset, and dedication to advancing healthcare, Peter Coffaro is a valuable asset and leader in the medical device industry.

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