Despite FDA Concerns, Panel Backs Mela Sciences’ Device

An FDA advisory panel backed a new dermatology diagnostic despite agency concerns about its safety and uncertainty over its intended use. The General and Plastic Surgery Devices Panel voted 10–6 that Mela Sciences’ MelaFind was safe; 8–6, with two abstentions, that it was effective; and 8–7, with one abstention, that the benefits outweighed the risks. The device is intended as a tool to help clinicians evaluate atypical skin lesions, including melanomas.
Devices & Diagnostics Letter