General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

November 18, 2010, from 8:00 a.m. to 6:00 p.m

MelaFind -sponsored by MELA Sciences, Inc.

Agenda: On November 18, 2010, the committee will discuss, make recommendations, and vote on premarket approval application for MelaFind, sponsored by MELA Sciences, Inc. MelaFind is a non-invasive computer vision system intended to assist in the evaluation of pigmented skin lesions, including atypical moles, which have one or more clinical or historical characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind acquires and displays multi-spectral (from blue to near infrared) digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma.