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Electro-Optical Sciences’ MelaFind melanoma detector

This article was originally published in The Gray Sheet

Executive Summary

Firm files PMA application June 4 for use of the handheld, non-invasive device to assist in the early diagnosis of melanoma, the leading cause of death from skin cancer. The PMA is supported by pivotal trial data showing 95% sensitivity, with specificity "statistically significantly higher than that of study clinicians," according to the company. While dermatologists typically diagnose melanoma with their naked eyes, MelaFind uses 10 different wavelengths of light to analyze skin lesions and help clinicians decide whether to perform a biopsy. FDA granted the PMA "expedited review" status while it was still in the planning stages in October 2006; the agency grants expedited review - placing the PMA at the head of the pre-market review queue - in cases where "a device offers a potential for clinically meaningful benefit as compared to the existing alternatives ... or when the new medical device promises to provide a revolutionary advance," according to FDA (1"The Gray Sheet" Feb. 5, 2007, p. 15)
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