Canon Medical Receives FDA Clearance for Alphenix 4D CT with Aquilion ONE/INSIGHT Edition

Canon Medical has announced FDA clearance for its most advanced interventional imaging system to date, the Alphenix 4D CT with Aquilion ONE/INSIGHT Edition. Set for commercial release in summer 2026, the hybrid Angio-CT solution will be prominently featured at the Radiological Society of North America (RSNA) 2025 annual meeting.

Combining the high-definition capabilities of the Alphenix Sky+ angiography system with the speed and precision of the Aquilion ONE/INSIGHT CT scanner, this next-generation platform is designed to streamline the entire interventional radiology workflow. The integrated setup enables clinicians to diagnose, plan, treat, and verify procedures all within a single room, reducing patient transfers and maximizing procedural efficiency.

The Alphenix Sky+ stands out for its industry-first high-definition flat panel detector featuring 76 µm pixel resolution, offering unparalleled clarity for image-guided interventions. Paired with the Aquilion ONE/INSIGHT Edition’s 16 cm wide-area detector and Canon’s AI-driven Precise IQ Engine (PIQE) for Deep Learning Reconstruction, the system delivers fast, full-organ imaging in a single 0.24-second rotation.

"This new system offers us new therapeutic possibilities thanks to unparalleled precision and greater procedure safety,” said Professor Guiu of the Centre Hospitalier Universitaire (CHU) of Montpellier, which became the first global site to install the combined Alphenix 4D CT and Aquilion ONE/INSIGHT Edition.

Canon’s integrated solution is designed for flexibility across numerous specialties including oncology, cardiology, pediatrics, neurosurgery, trauma, and interventional radiology. It is particularly well-suited for complex procedures requiring real-time imaging precision and minimal patient movement.

“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 of Canon Medical Systems USA. “We are proud that Canon Medical’s Alphenix 4D CT system is adopted globally to support patient care.”

With the tagline “One Room. Endless Possibilities,” Canon’s Angio-CT solution reflects a vision for the future of interventional care—uniting high-precision angiography with ultra-fast volumetric CT in a single suite to optimize outcomes and safety for both patients and clinical teams.