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Clarius Mobile Health Gets FDA Nod for AI Ultrasound Musculoskeletal Imaging Model


In what is reportedly the first Food and Drug Administration (FDA) 510(k) clearance for the use of artificial intelligence (AI) for musculoskeletal ultrasound, the model provides automated measurements of tendons in the knee, ankle, and foot.

Offering real-time identification and automated tendon measurements of the patellar tendon, plantar fascia and Achilles tendon, a new artificial intelligence (AI)-powered musculoskeletal ultrasound imaging application has received 510(k) clearance from the Food and Drug Administration (FDA).

Clarius Mobile Health said the AI model identifies viewed tendons with a transparent color overlay, labels the tendon and provides subsequent measurement calipers that align with the bottom and top of the tendon at its thickest region. Users of the AI musculoskeletal ultrasound application can then adjust the measurements to facilitate clinical decision-making, according to the company.

Alan Hirahara, M.D., says the new AI musculoskeletal application is “ground-breaking technology” that will assist new ultrasound users in learning musculoskeletal structures and enhance efficiency for radiologist assessment of musculoskeletal structures.

“The technology will … 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 … ,” noted Dr. Hirahara, an orthopedic surgeon in private practice in Sacramento, Calif.

Clarius Mobile Health said the musculoskeletal AI model will soon be available through its Clarius L7 HD3 and Clarius L15 HD3 handheld ultrasound scanners.

(Editor’s note: For related content, see “Pie Medical Imaging Launches AI-Powered Echocardiography Platform” and “Samsung Gets FDA Nod for Versatile V7 Ultrasound System.”)

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