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Article
FDA panel gives lukewarm nod to MelaFind device
The Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Panel has endorsed - albeit grudgingly - a novel device designed to help doctors evaluate atypical skin lesions, including melanoma, Medscape Medical News reports.
Washington – The Food and Drug Administration’s (FDA) General and Plastic Surgery Devices Panel has endorsed - albeit grudgingly - a novel device designed to help doctors evaluate atypical skin lesions, including melanoma, Medscape Medical News reports.
The panel endorsed MelaFind, from Mela Sciences of Irvington, N.Y., despite a negative FDA review of the device. The review came shortly before panel members voted on whether they thought the device was safe, effective and had a good risk-to-benefit ratio.
Medscape Medical News quotes Peter Rumm, deputy director of the FDA’s Plastic & Reconstructive Surgery Devices branch, as saying, “We have significant concerns that this device has not been studied adequately for its currently proposed indication. We are really struggling with how this device would actually be used in clinical practice.”
A member of the FDA review team said Mela Sciences did not demonstrate true additive value of using the device on atypical lesions. The member recommended a new prospective study of MelaFind.
