AI-Powered Detection System for Skin Cancers Receives FDA Approval
Source: Oncology Nursing News, February 2024
The first real-time, non-invasive skin cancer evaluation system, which can detect basal cell carcinoma, melanoma, and squamous cell carcinoma, has been granted clearance by the FDA, according to a press release from DermaSensor Inc.
The approval of this handheld, wireless device was based on data from both the blinded validation DERM-SUCCESS study (NCT05126173), which included 1,579 lesions biopsied in 1,005 patients, and the supplemental melanoma DERM-ASSESS III validation study. Investigators reported that the device had a sensitivity rate of 95.5% across all skin cancers, improving primary care providers’ (PCPs) cancer prediction rates by 12.5% (P < 0.0001). With the device the sensitivity rates were 87.5%, 97.8%, and 98.7% when detecting melanoma, basal cell carcinoma, and squamous cell carcinoma, respectively. The overall specificity rate of the device was 20.7%.
“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,” Cody Simmons, cofounder and chief executive officer of DermaSensor, stated in the press 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.”