eCART vs DermaSensor

A primary care physician can try DermaSensor on a monthly rental under a one-year device use agreement with a try-and-return option, and the vendor publishes no price for an outright purchase. FDA granted De Novo DEN230008 in January 2024 for use by physicians on lesions suspicious for skin cancer. The device scans a lesion already judged suspicious and returns "Monitor" or "Investigate Further" with a 1 to 10 score. Vendor figures give 96% sensitivity in DERM-SUCCESS, a multi-reader, multi-case study, and specificity of 33% in DERM-ASSESS III, a multicenter prospective blinded study, so many scans come back "Investigate Further". The vendor also says a dedicated CPT code has not yet been established and that EHR integration is still to come.

AgileMD sells to hospitals. eCART is cleared for hospitalized ward patients 18 and older, and the vendor cites 400+ hospitals. A primary care group scanning skin lesions and a hospital quality office scoring ward patients are buying for different clinical settings.