The US Food and Drug Administration (FDA) has issued an approvable letter to Mela Sciences for the MelaFind pre-market approval application.
MelaFind is a non-invasive and objective multi-spectral computer vision system designed to assess clinically atypical pigmented skin lesions.
The application for MelaFind is supported by the study which included 1,383 patients and 110 dermatologists.
The study showed that the device had a 98% sensitivity in the pivotal trial, whereas dermatologists had a 72% sensitivity in the adjunctive reader study.
Mela Sciences intends to work with the agency to finalise the physician and patient labelling, package insert, user’s guide, training programme and clinical protocol for a post-approval study to obtain final approval.