Mela Sciences has received CE mark approval for its MelaFind system which detects early melanoma, the deadliest form of skin cancer, which allows the company to market the system in 27 nations that comprise European Union.
The company is planning to initially market the system in Germany, which has high incidence of melanoma in Europe.
The CE Mark has been obtained based on a 1,383-patient US pivotal trial and the companion reader study of 110 dermatologists.
MelaFind is a non-invasive and objective multi-spectral computer vision system designed to assess clinically atypical pigmented skin lesions.
The evaluation aids dermatologists to receive complete information before making a final decision on biopsy to eliminate melanoma.
MelaFind acquires and displays multi-spectral and reconstructed RGB digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition.
Mela Sciences worked with the US Food and Drug Administration (FDA) to design the study and submitted a PMA application for MelaFind and is now awaiting for the FDA’s approval.