The U.S. Food and Drug Administration (FDA) has granted clearance to DermaSensor for its artificial intelligence (AI)-powered skin cancer detection device, marking a significant milestone in the field of AI in healthcare. This is the first AI device that can detect all major skin cancers, including melanoma, basal cell carcinoma, and squamous cell carcinoma.
The DermaSensor device is a wireless, handheld tool that uses a form of optical spectroscopy known as Elastic Scattering Spectroscopy (ESS). This technology takes noninvasive samples of tissue, capturing cellular-level information. The device uses hundreds of wavelengths of light in a manner similar to how sonar uses sound. Physicians can use this AI-powered spectroscopy technology to non-invasively examine lesions at cellular and subcellular levels.
The device then provides an immediate, objective result using an FDA-cleared algorithm. The algorithm was trained on over 20,000 spectral recordings from more than 4,000 patients. The device is designed to offer primary care physicians a real-time, non-invasive tool to detect all common skin cancers.
Clinical Trials and Results
The FDA clearance is based on a study which showed that the device had a 96% sensitivity in detecting skin cancers. When the device produced a negative result, it meant a 97% chance of being benign for all skin cancers. The device’s sensitivity was highest for basal and squamous cell carcinoma (98% and 99%, respectively) and lowest for melanoma (88%).
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%).
Impact on Healthcare
The device is expected to improve primary care and dermatology collaboration, enabling better-prioritized referrals and the referral of more patients with skin cancer. This is particularly significant as primary care physicians (PCPs) are the most abundant clinicians in the country and often the first point of contact for patients with suspicious moles. The device provides PCPs with an automated tool to evaluate skin cancer, a long-standing unmet need in medicine.
DermaSensor’s CEO, Cody Simmons, stated, “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”.
The FDA is requiring that DermaSensor conduct additional post-market clinical validation. The device will be priced through a subscription model. The company believes that its device can improve primary care and dermatology collaboration, enabling better-prioritized referrals and the referral of more patients with skin cancer.