FDA Approves First AI Ultrasound Scanner for Musculoskeletal Imaging

New musculoskeletal (MSK) imaging will soon be available through wireless handheld ultrasound scanners made by Clarius Mobile Health.

Clarius, a provider of high-definition handheld ultrasound systems, received approval by the U.S. Food and Drug Administration this week for its new MSK AI model. The MSK model will automatically identify and measure tendons of specific anatomical sites including the plantar fascia (foot), Achilles tendon (ankle), and patellar tendon (knee) using artificial intelligence (AI) with the Clarius L7 HD3 and Clarius L15 HD3 high-frequency scanners. These two scanners were introduced last year.

"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," said Clarius President and CEO Ohad Arazi said.

According to the company's website, the Clarius L7 HD3 delivers superior ultrasound for shallow structures and superficial anatomy with imaging optimized to 11 cm. Outside of MSK, the L7 HD3 model is also ideal for Breast, Lung, Ocular, Small Parts and Vascular scanning.

The Clarius L15 HD3 delivers high-definition imaging of superficial structures, from tiny nerves and vessels to musculoskeletal and lung imaging up to 7 cm. Outside of MSK, the L15 model is also ideal for Breast, Nerve, Small Parts, Superficial and Thyroid scanning.

Use of the scanners with the Clarius MSK AI model will streamline workflows, inform clinical management, and provide training assistance during the musculoskeletal scanning, according to the company.

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.

With the Clarius HD3 line of handheld ultrasound scanners, they are now used worldwide as a more affordable and easier-to-use alternative to traditional ultrasound systems, according to the company.

Scanners are available starting at $3,395 with $595 annual membership. This is an affordability improvement as costs for Clarius scanners were $6,900 and $9,900 in 2016.

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 said. "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."

Arazi added that "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."

"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."