Please ensure Javascript is enabled for purposes of website accessibility Canon Medical Systems USA Receives FDA 510(k) Clearance for Alphenix / Evolve Edition with αEvolve Imaging – Debuted at TCT 2025 | Canon Medical Systems USA

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November 25, 2025

Canon Medical Systems USA Receives FDA 510(k) Clearance for Alphenix / Evolve Edition with αEvolve Imaging – Debuted at TCT 2025

TUSTIN, CA – November 25, 2025 – Canon Medical Systems USA announced that its latest innovation in interventional cardiology imaging—the Alphenix / Evolve Edition with αEvolve Imaging—had received FDA 510(k) clearance, paving the way for enhanced procedural precision and clinical confidence.

Utilizing deep learning technology in real-time, the Alphenix / Evolve Edition is designed to enhance fluoroscopic imaging quality during routine and complex percutaneous coronary interventions (PCI). The Alphenix / Evolve Edition offers a range of industry-leading solutions for the Interventional Cardiology suite. Under the αEvolve (alpha Evolve) technology umbrella, which includes AI solutions, these tools provide real-time support for critical diagnostic and therapeutic decisions without disrupting the procedural flow.

αEvolve Imaging employs deep learning-based noise reduction and multi-frequency processing to deliver sharp, clear fluoroscopic images. The Dynamic Device Stabilizer (DDS), trained with deep learning, automatically detects balloon markers in real-time, magnifies, and stabilizes the image on a separate screen to assist with stent visualization and assessment during complex PCI procedures. Additionally, the Alphenix / Evolve Edition introduces a new level of intelligence and efficiency to modern interventional angiography suites through existing technologies such as:

  • Artificial Intelligence Denoising (AID) for reduced image noise during fluoroscopy
  • Multi-Frequency Processing (MFP) to maintain image detail and enhance visibility
  • αEvolve technology is currently available for 6” and 8” field of view 12×12-inch High-Definition flat panel detectors, depending on system configuration.

Extensive internal bench testing and real-world clinical image reviews demonstrated significant improvements in image contrast, sharpness, and noise levels, supporting more confident and efficient interventions.

Canon Medical Systems USA showcased the Alphenix/Evolve Edition with αEvolve Imaging at the Transcatheter Cardiovascular Therapeutics (TCT) Conference, which was held from October 25 to 28, 2025, at the Moscone Center in San Francisco, CA.

“Our commitment to empowering healthcare professionals with intelligent imaging tools has led to this milestone, an FDA 510 (k) clearance,” said Bill Newman, Vice President Interventional Vascular, Canon Medical Systems USA. “αEvolve Imaging brings meaningful innovation to interventional cardiology—helping teams visualize with greater clarity while maintaining procedural efficiency.”

The Alphenix / Evolve Edition is now commercially available in the United States*.

*αEvolve technology is currently available with 12×12-inch High-Definition flat panel detectors, depending on system configuration.