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DermaSensor, a Miami-based health technology company focused on skin cancer detection, has received Class IIb CE Mark certification for its handheld AI-powered device, opening the door for commercialization across the European Economic Area (EEA).
The milestone enables DermaSensor to expand beyond the United States and marks the beginning of the company’s broader international growth strategy. The CE Mark confirms that the device meets European Union requirements for safety, health, and environmental protection, allowing it to be marketed throughout Europe and in other regions that recognize CE certification.
Skin cancer remains one of the most common cancers worldwide, creating continued demand for technologies that can support earlier detection and improve access to specialist care. DermaSensor’s device is designed to help healthcare professionals assess suspicious skin lesions in real time at the point of care.
The handheld tool combines spectroscopy and artificial intelligence to non-invasively evaluate lesions and provide information on whether further clinical assessment, such as referral to a dermatologist or biopsy, may be warranted.
“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.
According to Simmons, the company is now focused on bringing its technology to healthcare providers across Europe following regulatory authorization.
DermaSensor’s technology has been evaluated through nine published studies conducted across more than 40 clinical sites involving hundreds of clinicians in both primary care and dermatology settings. The company states that the device’s performance and clinical utility have been demonstrated across these studies.
The solution is intended for use by qualified healthcare professionals to help determine whether suspicious skin lesions require additional clinical investigation.
In recent years, DermaSensor has also received industry recognition, including inclusion on TIME’s 2024 Best Inventions list and Inc. Magazine’s 2025 Best in Innovation list.
Alongside the CE Mark announcement, DermaSensor revealed a new feasibility study with the UK’s National Health Service (NHS). The collaboration will evaluate the impact of AI-assisted skin cancer assessment when used by general practitioners within NHS care settings.
Further details about the study are expected to be announced in the coming months.
The initiative reflects growing interest in how AI-enabled diagnostic tools can support frontline healthcare providers, particularly in settings where access to dermatology specialists may be limited.
To support its European rollout, DermaSensor recently entered into a strategic commercial partnership with a major European distributor. The partner also participated in the company’s recent Series B financing round with a $5 million investment.
The company is seeking additional collaborations with healthcare systems, commercial partners, and physician leaders as it works to expand adoption throughout Europe.
DermaSensor reports that its technology is already being used by hundreds of healthcare provider institutions in the United States, where thousands of patients are assessed using the device each month.
With CE Mark certification now secured and new partnerships emerging, the company is positioning itself to bring its AI-powered skin cancer assessment technology to a broader international audience.
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