Sam Brusco, Associate Editor01.17.24
DermaSensor gained U.S. Food and Drug Administration (FDA) clearance for its real-time, non-invasive skin cancer evaluation system, which can be used at the point of care.
The company’s artificial intelligence (AI)-powered spectroscopy tech non-invasively evaluates cellular and subcellular characteristics of a lesion in question for skin cancer. The device is wireless and handheld, and provides an immediate, objective results using its FDA-cleared algorithm.
The tech’s over 1,000-patient pivotal study showed the device had 96% sensitivity across all 224 skin cancers, and that a negative result had a 97% chance of being benign for all skin cancers. A companion clinical utility study with 108 physicians found that using DermaSensor decreased the number of missed skin cancers by half—from 18% to 9%.
“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 DermaSensor co-founder and CEO Cody Simmons. “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.”
The company’s artificial intelligence (AI)-powered spectroscopy tech non-invasively evaluates cellular and subcellular characteristics of a lesion in question for skin cancer. The device is wireless and handheld, and provides an immediate, objective results using its FDA-cleared algorithm.
The tech’s over 1,000-patient pivotal study showed the device had 96% sensitivity across all 224 skin cancers, and that a negative result had a 97% chance of being benign for all skin cancers. A companion clinical utility study with 108 physicians found that using DermaSensor decreased the number of missed skin cancers by half—from 18% to 9%.
“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 DermaSensor co-founder and CEO Cody Simmons. “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.”