European Regulators Approve DermaSensor Device

DermaSensor has initiated its global expansion strategy with the Class IIb CE Mark authorization for its DermaSensor device.

The CE Mark demonstrates that DermaSensor meets European Union standards for safety, health, and environmental protection and helps foster broader international adoption of the company’s non-invasive skin cancer detection technology. DermaSensor is currently seeking to work with commercial partners, healthcare systems, and physician thought leaders as it attempts to market 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,” DermaSensor Co-Founder/CEO Cody Simmons said. “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 U.S., given the FDA’s high bar for clinical evidence. We are excited to now have the regulatory authorization to make our product available to European healthcare providers (HCPs) and their patients.”

DermaSensor’s handheld device uses spectroscopy and artificial intelligence (AI) 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., referral to dermatology, biopsy). The device’s performance and benefits have been consistently demonstrated across nine published studies conducted with more than 40 clinical study sites and hundreds of clinicians in both the primary care and dermatology settings. The device has also recently received dozens of 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.

In addition to CE Mark certification, the company also announced a feasibility study in collaboration with the National Health Service (NHS) to evaluate the impact of AI-assisted skin cancer assessment when used by GPs within the NHS setting.

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 United States with hundreds of healthcare provider institutions that are collectively using the devices on thousands of patients a month.

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 AI and spectroscopy to non-invasively test skin lesions for skin cancer risk in seconds. DermaSensor is cleared by the U.S. Food and Drug Administration (De Novo), CE Marked, and is currently available for U.S. sale.