FDA clears DermaSensor’s AI detection device for skin cancer

Betsy Goodfellow | January 18, 2024 | News story | Medical Communications FDA, Oncology, skin cancer 

DermaSensor has announced that the US Food and Drug Administration (FDA) has granted clearance for its real-time, non-invasive skin cancer evaluation system. The AI-powered medical device is equipped to detect all three common skin cancers, melanoma, basal cell carcinoma and squamous cell carcinoma.

The FDA approval follows a pivotal study of over 1,000 patients, which demonstrated that the device had a sensitivity of 96% across all 224 skin cancers. A negative result had a 97% chance of being benign.

In another study, the device was demonstrated to reduce the number of missed skin cancers by half (from 18% to 9%).

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Cody Simmons, co-founder and chief executive officer of DermaSensor, commented: “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 optimise disease detection and care. Equipping 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.”

Betsy Goodfellow

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