DermaSensor FDA Cleared for Skin Cancer Detection

DermaSensor, a medtech company designing tools to better equip primary care physicians for skin cancer detection, recently announced FDA clearance of its real-time, non-invasive skin cancer evaluation system.

PCPs tend to be a more accessible option for some patients, especially in rural areas, meaning that the evaluation of suspicious moles tend to first come to them before potential referral to dermatology. Currently, PCP’s have limited options for evaluating whether a mole could be melanoma, basal cell carcinoma, or squamous cell carcinoma, and usually rely on the naked eye or magnified visual examination of lesions. Both examination methods are dependent on clinical training and subjective judgement, according to the Cochrane Database of Systematic Reviews.

In comparison, DermaSensor uses “AI-powered spectroscopy technology to non-invasively evaluate cellular and subcellular characteristics of a lesion in question of skin cancer,” according to the press release. “The wireless, handheld device then provides an immediate, objective result using an FDA-cleared algorithm.”

In an FDA pivotal study of over 1,000 patients — led my Mayo Clinic across 22 study centers — the device was evaluated for performance, showing that it had a sensitivity of 96% across all 224 skin cancers. Additionally, negative results had a 97% chance of being benign.

A comparison clinical utility study with 108 physicians also revealed that the device 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 Cody Simmons, co-founder and CEO of DermaSensor, in the release. “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 also noted potential benefits for dermatologists, citing improved primary care and dermatology collaboration, “enabling better-prioritized referrals in addition to the referral of more patients with skin cancer.”