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 bring this technology to physicians and patients across Europe.”
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.