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 that its 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, these AI tools support standardised, 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.
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 of all our investigators and scientists for their dedication in achieving these certifications, which will help support clinicians in detecting skin cancer,” said Doug Canfield, President of 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, PhD, 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/
* 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.
