Providing a more accurate way of identifying skin cancer will enable patients to access necessary treatment more quickly.

According to current estimates, one in five Americans will develop skin cancer in their lifetime. The three most common skin cancers are basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma, the most dangerous form of skin cancer because of its tendency to spread.

If caught early, skin cancer is highly treatable, but it makes early diagnosis crucial. Until now, detection has relied on the naked eye or magnified visual examination of skin lesions, which is dependent upon clinical training and the subjective judgment of primary care physicians (PCPs). However, the FDA recently upped the detection game, granting clearance to DermaSensor, the first AI-powered device to detect all three common skin cancers in real time.

"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 county, 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."

It's important to pause here to explain the difference between 'FDA approved' and 'FDA cleared'. Medical devices intended for human use fall into three categories. Class III are complex, implanted devices and products, like pacemakers and breast implants. They require FDA approval, meaning their benefits outweigh the known risks for their intended use, proven using data from clinical trials. Lower-risk devices and products for external use fall into Class I or II (for example, the ECG app for the Apple Watch is in Class II). These devices are 'cleared' rather than approved, meaning the FDA has allowed a device to market because it's "substantially equivalent" (in terms of safety and efficacy) to another legally marketed device.