Electro-Optical Sciences anounced that it has submitted a Premarket Approval Application to the U.S. Food and Drug Administration for MelaFind, a non-invasive, point-of-care imaging device to assist in the diagnosis of melanoma.
Earlier this year, the Irvington, NY-based company announced positive results in a large-scale clinical study of MelaFind. The device demonstrated 98 percent sensitivity and 9.5 percent specificity (compared to 3.5 percent for the dermatologists who participated in the study). Melanoma is responsible for approximately 80 percent of skin cancer fatalities, but it is highly treatable if caught early. The MelaFind device captures images of suspicious pigmented skin lesions, then analyzes them against a database of melanomas and skin lesions. MelaFind is intended to assist physicians in deciding whether to perform a biopsy.
Related video: Joseph V. Gulfo, President and CEO of Electro-Optical Sciences