DermaSensor, a health technology company transforming skin cancer detection with AI-powered technology, today announced it has received Class IIb CE Mark for the DermaSensor device, enabling commercialization across the European Economic Area (EEA) and marking the beginning of the company’s global expansion strategy.

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DermaSensor Device

The CE Mark demonstrates that DermaSensor meets European Union standards for safety, health, and environmental protection and paves the way for broader international adoption of the company’s non-invasive skin cancer detection technology. The company is now seeking to work with top-tier commercial partners, healthcare systems, and physician thought leaders as the company aims to gain widespread adoption of its device in 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, 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. 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.”

DermaSensor’s handheld device uses spectroscopy and artificial intelligence to test suspicious skin lesions for cancer in real time at the point of care. The DermaSensor solution is CE marked for use by qualified healthcare professionals to inform whether suspicious lesions merit further clinical care (e.g. refer to dermatology, biopsy). The device’s performance and benefits have been consistently demonstrated across nine published studies conducted with over 40 clinical study sites and hundreds of clinicians in both the primary care and dermatology settings. The device has also recently received dozens of prestigious awards and recognitions, including TIME’s 2024 Best Invention List and Inc Magazine’s 2025 Best in Innovation alongside companies such as Anthropic and Nvidia.

Skin cancer remains one of the most common cancers worldwide, with growing demand for tech-enabled solutions that can help improve access to early detection. The CE Mark certification positions DermaSensor to pursue commercial opportunities with healthcare systems, physician networks, and distribution partners throughout Europe and other international markets that recognize CE Mark standards.

The company is also today announcing a feasibility study in collaboration with the National Health Service (NHS), focused on evaluating the impact of AI-assisted skin cancer assessment when used by GPs within the NHS setting. Additional details regarding the collaboration will be announced in the coming months.

DermaSensor also recently entered into a strategic commercial partnership with a large European distributor to support commercialization efforts and accelerate market access within certain of Europe’s largest healthcare markets. This commercial partner invested $5 million in DermaSensor’s recent Series B financing. The company is actively seeking additional commercial partners, leading healthcare systems, and physician thought leaders as the company aims to gain broad adoption in Europe as it has already done in the US with hundreds of healthcare provider institutions that are collectively using the devices on thousands of patients a month.

If you are interested in being a potential partner with DermaSensor, please provide information online through DermaSensor’s website.

About DermaSensor

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to effectively check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device is a cost-effective handheld tool that uses artificial intelligence and spectroscopy to non-invasively test skin lesions for skin cancer risk in seconds. By enabling quick and effective skin cancer checks, DermaSensor ultimately hopes to improve skin cancer detection and save lives. DermaSensor is FDA Cleared (De Novo), CE Marked, and is currently available for sale in the U.S.

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Global Expansion Begins