Tustin, Ca, Nov. 25, 2025 (GLOBE NEWSWIRE) -- 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 12x12-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 12x12-inch High-Definition flat panel detectors, depending on system configuration.
To explore the full capabilities of the Alphenix / Evolve Edition with αEvolve Imaging, visit us at RSNA or connect with your local Canon Medical representative.
About Canon Medical Systems USA, Inc.
Canon Medical Systems USA, Inc., headquartered in Tustin, Calif., markets, sells, distributes and services radiology and cardiovascular systems, including CT, MR, molecular imaging, ultrasound, X-ray, and Interventional X-ray/Vascular equipment. For more information, visit Canon Medical Systems’ website: https://us.medical.canon/
About Canon Medical Systems Corporation
Canon Medical offers a full range of diagnostic medical imaging solutions, including CT, X-Ray, Ultrasound, Interventional X-ray/Vascular and MR, as well as a full suite of Healthcare IT solutions across the globe. In line with our continued Made for Life philosophy, patients are at the heart of everything we do. Our mission is to provide medical professionals with solutions that support their efforts in contributing to the health and wellbeing of patients worldwide. Our goal is to deliver optimum health opportunities for patients through uncompromised performance, comfort, and safety features. At Canon Medical, we work hand-in-hand with our partners – our medical, academic and research communities. We build relationships based on transparency, trust, and respect. Together, we strive to create industry-leading solutions that deliver an enriched quality of life. For more information, visit the Canon Medical website: https://global.medical.canon/
Olivia Duarte Canon Medical Systems USA (800) 421-1968 oduarte@us.medical.canon