The US Food and Drug Administration (FDA) has sent an Approvable Letter for Mela Sciences's MelaFind Pre-Market Approval (PMA) application.
MelaFind is a non-invasive and objective multi-spectral computer vision system designed to assess clinically atypical pigmented skin lesions.
The studies used to support the PMA application for MelaFind were the 1,383 patient US pivotal 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.
New York University Medical School Dermatology clinical professor Darrell Rigel said MelaFind has the potential to provide dermatologists with more information about indeterminate pigmented skin lesions to help them when deciding on which lesions to biopsy to detect melanoma as early as possible.
University of Pittsburgh Department Dermatology Clinical Trials Unit director and Dermatology assistant professor Laura Ferris said taken together, the multiple clinical trials demonstrate that MelaFind represents an advance and should have a positive impact on patient outcomes once it’s approved and available to dermatologists.
Mela Sciences intends to work with the FDA to finalize 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.