DermaSensor, the Miami-based health technology company that developed an AI-powered skin cancer detection device, is expanding into Europe after securing a key regulatory certification that opens the door to commercialization across much of the continent.
The company announced today that it has received Class IIb CE Mark certification for its handheld skin cancer assessment device, allowing sales throughout the European Economic Area and marking the start of its international growth strategy.
The CE Mark signifies that the device meets European Union standards for safety, health and environmental protection. The approval follows years of clinical validation and comes as DermaSensor looks to build partnerships with healthcare systems, distributors and physician leaders across Europe.
“This is a transformative milestone for DermaSensor and an important step in our mission to improve access to skin cancer detection globally,” said Cody Simmons [pictured above], co-founder and CEO of DermaSensor. “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.”
The company is already commercially active across the United States, where hundreds of physicians, private practices and health system partners use the device to help assess suspicious skin lesions for thousands of , Simmons said in an interview with Refresh Miami. He added that DermaSensor’s growth in the U.S. has accelerated in recent months, with additional commercial announcements expected in the next few months.
DermaSensor’s technology uses spectroscopy and artificial intelligence to analyze suspicious skin lesions in real time at the point of care. The non-invasive device is designed to help healthcare professionals determine whether a lesion warrants further evaluation, such as referral to a dermatologist or a biopsy. The device’s performance has been demonstrated through nine published clinical studies involving more than 40 study sites, and DermaSensor has earned spots on TIME’s Best Inventions of 2024 and Inc. Magazine’s 2025 Best in Innovation list. Last October, the company raised $16 million to support its commercialization.
Simmons noted that obtaining the European certification required “very rigorous” reviews of the company’s manufacturing and quality systems, complementing the extensive clinical evidence review previously conducted by the U.S. Food and Drug Administration. DermaSensor received FDA authorization in 2024.
While the new certification applies throughout the EEA, the United Kingdom remains outside the CE Mark framework following Brexit. Simmons said DermaSensor is pursuing regulatory authorization in the UK.
The expansion announcement is accompanied by the announcement of a new feasibility study with the United Kingdom’s National Health Service. The collaboration will evaluate the impact of AI-assisted skin cancer assessments when used by general practitioners within the NHS system. Additional details are expected in the coming months.
DermaSensor also disclosed that a major European commercial partner recently invested $5 million in the company’s Series B financing round. The distributor will help accelerate market access in several of Europe’s largest healthcare markets.
Now with a team of 18 full-time employees plus contractors, Simmons said DermaSensor is focused on three priorities: continuing U.S. commercial growth, launching international operations and expanding its product portfolio with new AI algorithms that can operate on the company’s existing hardware platform.
Although Europe is currently the primary international focus, Simmons said regulatory approvals from both the FDA and European authorities could help simplify entry into additional global markets in the future, including in Latin America and Asia.
“We’re looking for partners abroad to help commercialize this technology,” Simmons said. “Rest of the world, here we come.”
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