DEXI® and Lesion Visualizer Reach a New Regulatory Milestone Under the EU Medical Device Regulation
Artificial intelligence continues to expand its role in dermatology, particularly as clinicians look for technologies that can bring greater standardization and objective data into lesion assessment.
Canfield Scientific, Inc. has announced a significant milestone for two of its AI-powered decision support solutions. DEXI® and Lesion Visualizer have received CE marking under Regulation (EU) 2017/745 on medical devices, commonly known as the EU Medical Device Regulation or MDR. The certifications apply to lesion assessment in Europe. Canfield Scientific’s MDR Appro…
The announcement comes ahead of Canfield Scientific’s presence at EADV in Vienna and represents another step in the company’s continued development of imaging and AI technologies for dermatology.
What Are DEXI® and Lesion Visualizer?
Both technologies are designed for trained clinicians and healthcare professionals experienced in skin cancer diagnosis. According to Canfield, the AI tools are intended to support the standardized and objective assessment of suspicious cutaneous lesions. Canfield Scientific’s MDR Appro…
While the technologies work within the broader area of lesion assessment, they serve different purposes.
DEXI®, or Dermoscopy Explained Intelligence, has been classified as a Class IIb medical device under the EU MDR. The AI-powered technology is designed to support clinical decision-making for skin cancer assessment.
Lesion Visualizer has been classified as a Class IIa medical device and is designed to support lesion change detection. Canfield Scientific’s MDR Appro…
The imagery included in Canfield’s announcement provides a closer look at both technologies. On page one of the press release, Lesion Visualizer is shown displaying lesion imagery and changes over time, while DEXI is pictured being used alongside dermoscopic imaging to support lesion assessment.
Importantly, these tools are intended to support clinicians rather than replace clinical expertise. As AI becomes more integrated into medical imaging, the combination of technology, imaging data and professional interpretation is becoming an increasingly important part of the conversation.
AI Meets Clinical Decision-Making
Canfield’s announcement also points to research behind the technologies.
Prof. Dr. med. Lara V. Maul-Duwendag, Head of the Skin Cancer Prevention Unit at University Hospital Zürich, said that in a recent study, DEXI improved diagnostic performance and strengthened clinical decision-making, helping clinicians make more confident and informed diagnostic decisions. Canfield Scientific’s MDR Appro… Canfield Scientific’s MDR Appro…
Brian D’Alessandro, Ph.D., Principal AI Scientist at Canfield Scientific, described the future of dermatology as one in which AI and clinicians work together. He also pointed to the international body of research behind DEXI and Lesion Visualizer. Canfield Scientific’s MDR Appro…
That distinction matters. The conversation around AI in healthcare is rapidly moving beyond whether AI will be used toward a more practical question: how can it be integrated responsibly into clinical workflows to provide useful decision support?
For dermatology, where visual assessment and longitudinal imaging can play important roles, technologies capable of supporting more standardized analysis could become an increasingly significant part of that discussion.
A Milestone for Canfield Scientific
Canfield Scientific develops imaging systems, services and products for healthcare, scientific research and the medical aesthetic industries. The company says the new certifications reflect its continued investment in dermatologic imaging and technologies designed to support skin cancer research and screening. Canfield Scientific’s MDR Appro…
“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. Canfield Scientific’s MDR Appro…
For skincare and medical aesthetic professionals watching the evolution of advanced imaging, this milestone is another example of how AI is moving from an emerging technology conversation toward regulated clinical applications.
Regulatory note: DEXI® and Lesion Visualizer are available in the EU. In all other countries, both technologies are for research use only. Canfield Scientific’s MDR Appro…