Miami-based Dermasensor develops a handheld device that uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound.
Physicians can use its AI-powered spectroscopy technology to non-invasively evaluate lesions. They can look at cellular and subcellular characteristics of a lesion in question for skin cancer. The wireless device then provides an immediate, objective result using an FDA-cleared algorithm.
CE mark enables commercialization in Europe, marking the start of the company’s global expansion strategy. It builds on FDA clearance for the real-time, non-invasive, AI-powered skin cancer evaluation system in January 2025. DermaSensor also raised $16 million to support its commercial efforts in the fall.
DermaSensor now plans to work with “top-tier commercial partners, healthcare systems and physician thought leaders” to spur 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 HCP’s and their patients.”
DermaSensor also announces new collaboration and commercial partnership
In addition to CE mark, the company announced a feasibility study in collaboration with the UK’s National Health Service (NHS).
The study aims to evaluate the impact of AI-assisted skin cancer assessment when used by general practitioners (GPs) within the NHS setting. DermaSensor plans to share further details in the coming months.
Additionally, the company entered into a commercial partnership with a large European distributor to support commercial efforts and accelerate market access within certain large European healthcare markets.
DermaSensor said the partner invested $5 million in its recent Series B financing. It now looks to seek out additional commercial partners, leading healthcare systems and physician thought leaders to help accelerate broad adoption in Europe.
