Canon Medical Systems USA Unveils Their Latest Innovation in Interventional Imaging: Alphenix 4D CT with Aquilion ONE/INSIGHT Edition – Now U.S. Food and Drug Administration (FDA) 510(k) ClearedNovember 19, 2025 at 08:00 AM EST
Tustin, Ca, Nov. 19, 2025 (GLOBE NEWSWIRE) -- Canon Medical, a leader in medical device technology announces the FDA clearance of the most advanced interventional imaging equipment available — The Alphenix 4D CT with Aquilion ONE/INSIGHT Edition. With this clearance, Canon is on schedule to make the system commercially available in the summer, 2026. The Alphenix 4D CT with Aquilion ONE / INSIGHT Edition will be on display at the annual meeting of the Radiological Society of North America (RSNA 2025). This next-generation Angio-CT hybrid one-suite solution represents Canon’s unwavering 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 award-winning 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 powerful combination delivers cross-sectional imaging with an ultra-fast down to 0.24 second rotation speed and wide-area detector, enabling full organ coverage in a single rotation. The Centre Hospitalier Universitaire (CHU) of Montpellier serves as the first global installation of the Alphenix 4D CT in combination with Aquilion ONE / INSIGHT Edition. According to Professor Guiu, "This new system offers us new therapeutic possibilities thanks to unparalleled precision and greater procedure safety." “Our innovative technology meets the evolving needs of healthcare professionals, enhancing workflow and enabling our customers to prioritize clinical decisions for patients,” said Hisashi Tachizaki, President and CEO, CMSU. “We are proud that Canon Medical’s Alphenix 4D CT system is adopted globally to support patient care in the fields of interventional radiology, oncology, cardiology, pediatrics, neurosurgery, trauma, and other specialties.” One Room. Endless Possibilities. Designed to integrate the latest advances in interventional imaging, the Angio-CT solution includes in a single room: • An Alphenix Sky+ (high-precision angiography) • An Aquilion ONE / INSIGHT Edition scanner (ultra-fast volumetric imaging) This setup enables optimized patient care, with fewer transfers, enhanced precision, and dose optimization for both patients and medical teams. Visit Canon at RSNA 2025 Experience Canon's Interventional X-Ray/Vascular portfolio at RSNA 2025 in Chicago, November 30 – December 4, at the Canon Medical Booth #7313. Watch demonstrations of the AI workflow and discover the company's approach to vertical integration. Canon Medical invites RSNA registrants to our corporate lunch and learn symposia, “Imaging Elevated: Intelligent Technologies Shaping the Future of Diagnostics” on December 1st and “Shaping the Future of Imaging Through Innovation” on December 3rd, during the RSNA 2025 Annual Meeting. Attendees will gain exclusive insights into advancements in the newest generation of imaging technologies and the unique and novel uses of hybrid Angio-CT in Interventional Radiology and Oncology. For more information, please visit: https://us.medical.canon/news/events/rsna/ For more information about these technologies, visit the Canon Medical Systems USA website here. About Canon Medical Systems USA, Inc. About Canon Medical Systems Corporation ![]() Olivia Duarte Canon Medical Systems USA (800) 421-1968 oduarte@us.medical.canon More NewsView MoreVia MarketBeat
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