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Canon Medical Secures FDA Clearance for Ultrasound Innovations, Advancing Image Clarity and Workflow Efficiency

Tustin, Ca, Nov. 26, 2025 (GLOBE NEWSWIRE) -- Canon Medical Systems USA, Inc. recently received FDA 510(k) clearance for its Aplio i-series diagnostic ultrasound systems (Aplio i900, Aplio i800, and Aplio i700) with Software Version 9.0. This clearance introduces advanced imaging technologies designed to help clinicians achieve high-quality diagnostic images with greater efficiency.

The new software release includes three major innovations. First, 3rd Harmonic Imaging (3-HI) employs deep learning technology to filter and extract higher-order harmonic signals, producing ultrasound images with improved spatial and contrast resolution while reducing artifacts such as reverberation and sidelobes. This AI-powered feature is intended to deliver sharper, clearer images for improved diagnostic confidence.

Second, SMI Angio enhances Canon’s Superb Micro-vascular Imaging (SMI) technology by applying advanced statistical processing techniques to visualize microvascular flow with greater clarity. This improvement allows clinicians to more confidently evaluate tissue vascularity and branching patterns by distinctly delineating fine, closely spaced blood vessels.

Third, Auto Tune Shear Wave automates transmit and receive settings based on tissue stiffness, streamlining workflow and supporting accurate elasticity measurements. By reducing manual adjustments, this feature is designed to improve efficiency and may contribute to more consistent shear wave exams, by reducing variation within the measurement region of interest (ROI).

“FDA clearance of these advanced features demonstrates Canon Medical’s commitment to innovation that supports clinicians in delivering high-quality care,” said Dan Skyba, Sr. Managing Director, UL Business Unit, Canon Medical Systems USA. “Canon is proud to be the first to apply an Altivity powered deep learning AI filter to enhance ultrasound image quality. We are raising the flag for innovation and driving the evolution of the harmonic imaging revolution in ultrasound. By integrating AI and automation, we’re empowering clinicians with tools that deliver clarity, efficiency, and confidence.”

Visit Canon Medical at RSNA 2025 to experience the future of ultrasound imaging. Explore the Aplio i-series innovations, including 3rd Harmonic Imaging powered by Altivity deep learning AI, SMI Angio mode, and Auto Tune Shear Wave mode, at Booth #7313 in Chicago, November 30 to December 4. Watch live demonstrations of our advanced AI workflow and discover how Canon is driving the evolution to revolution in diagnostic imaging.

About Canon Medical Systems USA, Inc.
Canon Medical Systems USA, Inc., headquartered in Tustin, Calif., markets, sells, distributes and services radiology and cardiovascular systems, including CT, MR, molecular imaging, ultrasound, X-ray, and Interventional X-ray/Vascular equipment. For more information, visit Canon Medical Systems’ website: https://us.medical.canon/

About Canon Medical Systems Corporation
Canon Medical offers a full range of diagnostic medical imaging solutions, including CT, X-Ray, Ultrasound, Interventional X-ray/Vascular and MR, as well as a full suite of Healthcare IT solutions across the globe. In line with our continued Made for Life philosophy, patients are at the heart of everything we do. Our mission is to provide medical professionals with solutions that support their efforts in contributing to the health and wellbeing of patients worldwide. Our goal is to deliver optimum health opportunities for patients through uncompromised performance, comfort, and safety features. At Canon Medical, we work hand-in-hand with our partners – our medical, academic and research communities. We build relationships based on transparency, trust, and respect. Together, we strive to create industry-leading solutions that deliver an enriched quality of life. For more information, visit the Canon Medical website: https://global.medical.canon/


Olivia Duarte
Canon Medical Systems USA
(800) 421-1968
oduarte@us.medical.canon

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