MELA Sciences Recalls MelaFind
May 22, 2015
MELA Sciences is voluntarily recalling its flagship product, the MelaFind system for supplemental melanoma diagnosis, because of a lack of approval of the device’s user interface, the Irvington, N.Y., devicemaker says in a letter posted May 20.
Though the device received premarket approval, that did not extend to the on-screen user interface display, the FDA says. In Europe, the product is CE Marked.
MelaFind was developed to provide software-driven imaging analysis of pigmented skin lesions as a means of obtaining information when determining if a biopsy is necessary.
The FDA notice says there are 65 units in U.S. circulation. — Jason Scott