MelaFind comes a step closer to the US market with FDA approvable letter
This article was originally published in Clinica
Executive Summary
Mela Sciences' troubled melanoma detection device MelaFind finally looks likely to reach the US market after the company received an approvable letter from the FDA. The company must now agree a protocol with the agency for a post-approval study in order to obtain final approval, as well as finalising physician and patient labelling, the package insert, user's guide and training programme.