DermaSensor was awarded Breakthrough Device Designation by the FDA in 2021. Our hand- held, wireless system is expected to be the first device cleared by the FDA to assist PCPs in evaluating skin cancer (i.e., Melanoma, BCC and SCC). The device uses optical spectroscopy to non-invasively sample tissue beneath the surface of the skin, after which the machine learning algorithm analyzes the spectral data in just a few seconds to provide an immediate output directly to the user.