MelaFind features a hand-held imaging device that emits light of multiple wavelengths to capture images of suspicious pigmented skin lesions and extract data.
Using sophisticated algorithms, the data are then analyzed against a proprietary database of melanomas and benign lesions in order to provide information to the physician and produce a recommendation of whether the lesion should be biopsied, the company said.
Joseph Gulfo, president and CEO of Electro-Optical Sciences (EOS), said: “All follow-up data have been received, the pivotal trial sites have been closed, and the databases are undergoing third-party statistical validation. In addition, all image analysis algorithms including the classification algorithms are final, and in accordance with FDA design control requirements are undergoing software verification and validation.
“This work is being conducted by expert third-party contract research organizations and subcontractors. We look forward to unblinding the data and announcing top-line results within the next several weeks.”