Wikipedia
MelaFind was developed by a medical device company called, MELA Sciences, based in Irvington, NY. MelaFind is a non-invasive tool that provides additional information to dermatologists during melanoma skin examinations. The device uses light from visible to near-infrared wavelengths to evaluate skin lesions up to 2.5 mm beneath the skin. The device provides information on a lesion’s level of morphologic disorganization to provide additional objective information that may be used by dermatologists in the biopsy decision-making process. MelaFind received CE Mark approval in November 2011 and is approved for use in the European Union. MelaFind received approval by the US Food and Drug Administration in November 2011 for use in the US. MelaFind was listed as one of the Top 10 Medical Innovations for 2013 compiled by the Cleveland Clinic and received a bronze Edison award for its innovation.
The MelaFind pivotal study was the largest positive prospective clinical study ever conducted in melanoma detection with 1384 patients presenting 1831 skin lesions. The aim of this study was to establish the safety and effectiveness of MelaFind® using sensitivity and specificity as metrics. MelaFind® successfully met both set endpoints. The device demonstrated 98.3% sensitivity by correctly identifying 172 out of 175 melanomas and high-grade lesions. Dermatologists detected 72% of melanomas in the study. The median Breslow thickness of invasive melanomas in the pivotal study was 0.365 mm and 45% of all melanomas were in situ indicating melanomas tested were clinically challenging and in a treatable stage. MelaFind was more specific than dermatologists in the study; MelaFind demonstrated 10.8% specificity vs. 5.6% dermatologist specificity.