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MelaFind delayed after FDA raises questions

This article was originally published in Clinica

Executive Summary

Mela Sciences has hit a snag with the US approval of its melanoma detection device, MelaFind, after the FDA asked the company additional questions about its premarket approval (PMA) application. Mela is “actively working” to respond to these, but believes that the review time is likely to be extended by 180 days.

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