FDA Approves First AI-Powered Skin Cancer Diagnostic Tool



  • DermaSensor provides quantitative, point-of-testing identification for skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma.
  • The DermaSensor device uses artificial intelligence (AI)-powered spectroscopy to identify cellular and subcellular characteristics of lesions.
  • The approval follows an observational study (NCT05126173) that evaluated the device in over 1000 patients and was led by the Mayo Clinic.

The FDA has approved DermaSensor, the first AI-powered tool to diagnose skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma, at the point of testing and noninvasively.1

DermaSensor is a wireless, handheld device that uses spectroscopy technology to examine lesions at cellular and subcellular levels, then analyze those characteristics using an FDA-cleared algorithm.The device was evaluated in the DERM-SUCCESS study which was led by the Mayo Clinic across 22 study centers and enrolled over 1000 patients. The DermaSensor device demonstrated a 96% sensitivity across all 224 types of skin cancers. Further, negative results from DermaSensor had a 97% chance of being benign across all skin cancers.

A companion clinical utility study also investigated DermaSensor’s usage with 108 physicians. This study found that the device decreased the number of missed skin cancers by half (18% vs 9%).1 Further studies observed that the use of DermaSensor led clinicians to refer more patients for skin cancer (81% vs 94%).2

“Achieving this medical milestone is a testament to the 12 years and tens of millions of dollars our company has invested in research and development to bring this powerful technology to market,” said Maurice Ferre, MD, co-founder, and chairman of DermaSensor, said in a press release.“We are incredibly grateful to the FDA for their collaboration and dedication to this area starting with our first FDA pre-submission meeting in 2016. Having begun patient enrollment in our FDA pivotal study in mid-2020, we are now ecstatic to have clearance of our FDA-breakthrough designated de novo submission.”

The FDA granted breakthrough device designation to DermaSensor in 2021.3

“We are entering the golden age of predictive and generative artificial intelligence in healthcare, and these capabilities are being paired with novel types of technology, like spectroscopy and genetic sequencing, to optimize disease detection and care,” said Cody Simmons, co-founder, and chief executive officer of DermaSensor, in a press release.“Equipping [primary care physicians (PCPs)], the most abundant clinicians in the country, to better evaluate the most common cancer in the country has been a major, long-standing unmet need in medicine. While dozens of companies have attempted to address this problem in recent decades, we are honored to be the first device cleared by the FDA that provides PCPs with an automated tool for evaluation of suspicious lesions.”

1. FDA clearance granted for first AI-powered medical device to detect all 3 common skin cancers (melanoma, basal cell carcinoma, and squamous cell carcinoma). News release. DermaSensor. January 17, 2024. Accessed January 17, 2024. http://tinyurl.com/jye7euub
2. Silverwood, J. Study finds skin cancer detection device increases rate of clinician referral. News release. Medical Device Network. December 14, 2023. Accessed January 17, 2024. http://tinyurl.com/yc3va76n
3. DermaSensor Inc. announces successful completion of first ever FDA pivotal studies for skin cancer detection device for primary care. News release. DermaSensor. June 20, 2022. Accessed January 17, 2024. http://tinyurl.com/23e3kau8