Aquilion ONE/INSIGHT Edition (Photo: Canon Medical Systems)
Dec,. 1, 2025 — Canon has announced that the U.S. Food and Drug Administration (FDA) has granted [510(k) clearance/PMA approval] for its Alphenix 4D CT with Aquilion ONE/INSIGHT Edition, which follows a successful European launch in August. This next-generation Angio-CT hybrid one-suite solution (Alphenix 4D CT) represents Canon’s commitment to advancing interventional therapy with enhanced clinical workflows.
This advanced multi-modality solution is designed for the future of Interventional Radiology, combining the Alphenix Sky + angiography system with the Aquilion ONE/INSIGHT Edition CT scanner. It enables diagnosis, planning, treatment and verification in one room, all but eliminating the need for patient transfer between departments.
In addition to improving safety and patient care, the Alphenix Sky + provides the world’s only high-definition flat panel detector with its unique 76 µm pixel technology. The Aquilion ONE/INSIGHT Edition features a 16 cm wide-area detector and includes Canon’s Precise IQ Engine (PIQE) Deep Learning Reconstruction, and AI-assisted workflow experience. This combination delivers cross-sectional imaging with an ultra-fast 0.24 second rotation speed and wide-area detector, enabling full organ coverage in a single rotation.
“This clearance marks a significant milestone for our company and reflects our commitment to advancing patient care through innovation,” said Kunitoshi Matsumoto, General Manager of Interventional X-ray Systems Division, Canon Medical Systems Corporation. “The Alphenix 4D CT with Aquilion ONE/INSIGHT Edition provides Canon’s latest angiography innovation for body procedures and cardiac, combines AI-driven imaging with workflow intelligence, and is designed for safety, precision, and efficiency, empowering physicians to deliver better outcomes.”
The Centre Hospitalier Universitaire (CHU) de Montpellier serves as the first global reference site for the Alphenix 4D CT in combination with Aquilion ONE/INSIGHT Edition, highlighting Canon Medical’s commitment to clinical excellence through strategic partnerships with leading institutions and their specialized departments, such as Professor Boris Guiu’s interventional radiology department.
"This new system offers us new therapeutic possibilities thanks to unparalleled precision to date and greater procedure safety," said Professor Guiu. "We are proud to have been the pioneers of this technology in Europe in 2017 and to now be able to explore the new possibilities offered by this world first." Echoing the commitment, Canon’s Kunitoshi Matsumoto adds: “Canon has been a leader in Angio-CT technology for decades and continue to bring innovative technology to the Angio-CT suite. Strategic partnerships with global sites like Montpellier are critical for us to continue to bring this type of technology to market.”
February 12, 2026 
