Canon Medical Systems Secures FDA Clearance for Aquilion ONE/PRISM Edition

Canon Medical Systems received 510(k) clearance from the U.S. Food and Drug Administration on Wednesday for the Aquilion ONE/PRISM Edition.

This system, designed for deep intelligence, integrates artificial intelligence technology to maximize conventional and spectral CT automated workflow capabilities, as well as provide clinic insights to support patient-care decision-making. 

The Aquilion ONE/PRISM Edition uses the Advanced Intelligent Clear-IQ Engine (AiCE) for CT reconstruction. The product, which is trained on a significant amount of high-quality image data, employs deep learning to differentiate between true signal and noise to deliver clear images quickly.

“Canon Medical’s DLR technology is pushing routine diagnostic imaging into the age of AI assisted imaging, revolutionizing patient care by enabling excellent diagnostic confidence,” said Erin Angel, managing director of Canon Medical’s CT Business Unit. “With Deep Learning Spectral, Canon Medical is able to provide clinicians with a spectral CT system designed to address the trade-offs of traditional spectral CT and, potentially, expand the utilization to more routine CT imaging.”

AiCE can be applied, according to the company statement, to enhance the anatomical resolution for the whole body, including brain, lung, cardiac, and musculoskeletal applications. And, Aquilion ONE/PRISM Edition supports more confident diagnoses with rapid kV switching with patient-specific mA modulation, full field-of-view acquisition, and 16cm coverage. The end-to-end workflow can be integrated into routine protocols, company officials said.