On September 26, 2011, the FDA issued an approvable letter to Mela Sciences, the manufacturer of MelaFind, an investigational diagnostic device for early melanoma. This letter comes almost 1 year after the FDA rejected the device, requesting more clinical data. MelaFind is a noninvasive, multispectral computerized vision system that analyzes images of skin lesions. It is designed to differentiate nonulcerated, nonbleeding cutaneous malignant melanoma and high-grade lesions <2.2 cm from all other pigmented skin lesions. MelaFind showed 98.3% sensitivity and 9.9% specificity versus 3.7% specificity of standard diagnostic methods used by dermatologists.
