FDA approves MelaFind (Mela Sciences) for spotting Skin Lesions and Melanoma

The US FDA has approved the pre-market approval (PMA) application for the MelaFind Lesion Imaging System, from Mela Sciences. The MelaFind system provides doctors with information about pigmented Skin Lesions to help them decide which Lesions to biopsy in order to detect Melanoma as early as possible. Detection of early Melanoma and conducting prompt treatment is essential to improving patient prognoses. The studies used to support the PMA application were the 1,383-patient US trial and a companion reader study of 110 dermatologists. The device demonstrated a 98% sensitivity in the trial, and a similar sensitivity in the reader study compared to a 72% sensitivity for participating dermatologists. The company is now preparing to launch MelaFind in the Northeast US and Germany during the first quarter of 2012.