Canon Medical Systems USA has received FDA clearance for its Alphenix 4D CT with Aquilion ONE/INSIGHT Edition, a hybrid interventional imaging system that merges angiography and CT into a single room.

The Tustin, California-based company plans to make the system commercially available in the U.S. by summer 2026, and will feature it during the RSNA 2025 meeting in Chicago, running from November 30 to December 4.

The Alphenix 4D CT combines Canon’s Alphenix Sky+ angiography system with the Aquilion ONE/INSIGHT Edition CT scanner. The integrated solution enables clinicians to perform diagnostic imaging, procedure planning, intervention, and post-treatment verification without moving the patient between departments. The goal is to streamline workflows, improve patient safety, and reduce the time required for complex procedures.
The system’s CT component includes a 16 cm wide-area detector and Canon’s Precise IQ Engine (PIQE), which uses deep learning reconstruction for enhanced image quality. The scanner achieves full organ coverage in a single rotation, with a scan speed as fast as 0.24 seconds. The Alphenix Sky+ system incorporates a high-definition flat panel detector with 76-micron pixel resolution.

The first global installation of the system is underway at Centre Hospitalier Universitaire (CHU) of Montpellier in France. Professor Guiu, who is involved with the site, said, “This new system offers us new therapeutic possibilities thanks to unparalleled precision and greater procedure safety.”

Hisashi Tachizaki, president and CEO of Canon Medical Systems USA, said, “Our innovative technology meets the evolving needs of healthcare professionals, enhancing workflow and enabling our customers to prioritize clinical decisions for patients.”

Canon Medical will showcase the new system and host two educational symposia at RSNA 2025, focusing on imaging advances and the clinical use of hybrid Angio-CT in fields such as interventional radiology and oncology.

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