FDA supplies approval letter for MelaFind Melanoma imaging system

The FDA has issued an approval letter for the MelaFind Lesion Imaging System Pre-Market Approval application. MelaFind, from MELA Sciences, is a non-invasive multi-spectral computer imaging system intended for use on clinically atypical pigmented skin lesions with one or more characteristics consistent with Melanoma. The studies used to support the PMA application was a 1,383 patient US trial and the companion reader study of 110 dermatologists: the device demonstrated a 98% sensitivity in the pivotal trial, whereas dermatologists had a 72% sensitivity in the adjunctive reader study. MELA Sciences now intends to work with the FDA to finalise the physician and patient labeling, package insert, user's guide, training program and clinical protocol for a post-approval study in order to obtain final approval.