Canfield reaches a new milestone with their leading AI decision support solutions DEXI^®* and Lesion Visualizer^** achieving CE Marks under the EU Medical Device Regulation (MDR) for lesion assessment in Europe.

Parsippany, New Jersey – Canfield Scientific Inc., the leading provider of imaging systems, services, and products for the medical and skin care industries, announced their AI-decision support tools, Dermoscopy Explained Intelligence (DEXI^®) and Lesion Visualizer, have received CE marking under Regulation (EU) 2017/745 on medical devices (EU MDR).

Intended for trained clinicians and healthcare professionals experienced in skin cancer diagnosis, the AI tools support the standardized and objective assessment of suspicious cutaneous lesions. DEXI^* is classified as a Class IIb medical device and supports clinical decision-making for skin cancer assessment. Lesion Visualizer^** is classified as a Class IIa medical device and supports lesion change detection.

Canfield remains committed to driving continued innovation in dermatologic imaging, ultimately supporting enhanced skin cancer research and screenings worldwide.

“With our most recent study, we have found that DEXI has improved our diagnostic performance and strengthened clinical decision-making, enabling us to make more confident and informed diagnostic decisions,” said Prof. Dr. med. Lara V. Maul-Duwendag, Head of Skin Cancer Prevention Unit at University Hospital Zürich.

“We are very appreciative to all of our investigators and scientists for achieving these certifications to support clinicians in detecting skin cancer,” said Doug Canfield, President Canfield Scientific, Inc.

“The future of dermatology involves AI and the clinician working together. I am proud of Canfield's contributions to this area, and of the international body of research behind our work that has validated DEXI and Lesion Visualizer,” added Brian D'Alessandro, Ph.D., Principal AI Scientist.

For more information about Canfield’s quality certifications, please visit https://www.canfieldsci.com/quality-management-systems/

For detailed information on DEXI and Lesion Visualizer, please visit https://www.canfieldsci.com/imaging-systems/dermagraphix/

About Canfield Scientific

Canfield Scientific is the global leader in imaging systems, services and products for healthcare and scientific research. With a commitment to innovation and quality, Canfield develops state-of-the-art imaging solutions that empower practitioners in the medical and aesthetic industries to deliver superior results. Canfield’s products are trusted by leading institutions and research centers around the world for their precision, reliability, and ease of use.

For more information about Canfield Scientific, please visit https://www.canfieldsci.com/about/.

^{* Available in the EU. In all other countries, DEXI is for research use only.
** Available in the EU. In all other countries, Lesion Visualizer is for research use only.}