DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system.
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.
DermaSensor says 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.
A pivotal study of more than 1,000 patients found 96% sensitivity with the device across 224 skin cancers. When the device produced a negative result, it meant a 97% chance of being benign for all skin cancers. DermaSensor said its device also demonstrated the ability to cut the number of missed skin cancers in half (18% to 9%).
The company believes its device can improve primary care and dermatology collaboration. This enables better-prioritized referrals, plus the referral of more patients with skin cancer.
“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 CEO of DermaSensor. “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.”