Handheld AI Device for Point-of-Care Skin Lesion Assessment Receives CE Mark

The device uses spectroscopy and artificial intelligence to evaluate suspicious skin lesions at the point of care and provide immediate results. CE-marked for use by qualified healthcare professionals, it helps inform whether lesions merit additional clinical care, such as dermatology referral or biopsy. The tool is intended for real-time assessment in both primary care and dermatology settings.

Beyond the European clearance, the device is Food and Drug Administration (FDA) cleared through the De Novo pathway and is currently available for sale in the United States. The CE Mark positions the company to pursue commercial opportunities with healthcare systems, physician networks, and distribution partners across Europe and in other markets that recognize CE standards. Skin cancer’s global prevalence continues to drive demand for technology-enabled early detection.

Performance and benefits have been reported across nine published studies involving more than 40 clinical sites and hundreds of clinicians. The company also announced a feasibility study with the United Kingdom’s National Health Service (NHS) to evaluate the impact of AI-assisted assessment when used by general practitioners. In addition, a strategic partnership with a large European distributor will support commercialization and accelerate market access in several major European markets, following a $5 million investment in the company’s recent Series B financing.

The organization is seeking additional partners and healthcare systems as it expands in Europe. In the United States, hundreds of healthcare provider institutions are using the device with thousands of patients each month, according to the announcement. Recent recognition includes placement on TIME’s 2024 Best Inventions list and Inc. Magazine’s 2025 Best in Innovation list.

“This is a transformative milestone for DermaSensor and an important step in our mission to improve access to skin cancer detection globally. We are the first and only automated device authorized by the FDA for detection of all three common skin cancers as well as the first and only automated skin cancer tool that can be used by physicians who are not already experts in dermatology,” said Cody Simmons, Co-Founder and CEO of DermaSensor.

“While many companies have tried, no such tools that are currently available in Europe have been able to achieve approval in the US, given the FDA’s high bar for clinical evidence. We are excited to now have the regulatory authorization to make our industry-leading product available to European Healthcare Providers (HCP’s) and their patients,” added Simmons.

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