FDA Says Mela Sciences Device Needs New Study For Melanoma Detection

Article preview from "The Gray Sheet" - November 17, 2010

Mela Sciences should conduct a new study of its MelaFind melanoma detection system since the current data have not demonstrated "any true additive value" for its intended use, and the device "may potentially cause more harm than good," according to FDA reviewers.

FDA Says Mela Sciences Device Needs New Study For Melanoma Detection

Article preview from "The Gray Sheet" - November 17, 2010

Mela Sciences should conduct a new study of its MelaFind melanoma detection system since the current data have not demonstrated "any true additive value" for its intended use, and the device "may potentially cause more harm than good," according to FDA reviewers.

A PMA for the first-of-its-kind device is slated for review by FDA's General and Plastic Surgery Devices Panel on Nov. 18 in College Park, Md.

In its review summary prepared for the panel, the agency faults the firm's primary study and companion reader study for deviating from a protocol agreement.

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