Diagnosing Melanoma Early May Soon Be Easier: MelaFind Gets Approvable Letter
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.