The MelaFind melanoma detection system from MELA Sciences has received United States Food & Drug Administration approval following its pre-market approval application submitted to the FDA in June 2009. Earlier this year, the company received CE Mark approval from the European Union for the device, which the company plans to roll out concurrently in 2012 in Germany and the United States. “We are thrilled that our years of persistence through the development and regulatory process have paid off,” said Joseph V. Gulfo, MD, president and CEO of MELA Sciences. “We are ready to start this new phase in the company’s history with the same energy, passion and tireless dedication that was responsible for this tremendous and rewarding accomplishment.”
FDA Approves MelaFind
Jan 5th, 2012