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.”)
Could AI-Powered Abbreviated MRI Reinvent Detection for Structural Abnormalities of the Knee?
April 24th 2025Employing deep learning image reconstruction, parallel imaging and multi-slice acceleration in a sub-five-minute 3T knee MRI, researchers noted 100 percent sensitivity and 99 percent specificity for anterior cruciate ligament (ACL) tears.
The Reading Room: Artificial Intelligence: What RSNA 2020 Offered, and What 2021 Could Bring
December 5th 2020Nina Kottler, M.D., chief medical officer of AI at Radiology Partners, discusses, during RSNA 2020, what new developments the annual meeting provided about these technologies, sessions to access, and what to expect in the coming year.
Meta-Analysis Shows Merits of AI with CTA Detection of Coronary Artery Stenosis and Calcified Plaque
April 16th 2025Artificial intelligence demonstrated higher AUC, sensitivity, and specificity than radiologists for detecting coronary artery stenosis > 50 percent on computed tomography angiography (CTA), according to a new 17-study meta-analysis.