MELA Sciences announced that the FDA has finally issued an approval letter for the MelaFind Pre-Market Approval application. The device is a non-invasive and objective multi-spectral computer vision system intended for use on clinically atypical pigmented skin lesions with one or more characteristics consistent with melanoma. Using a series of algorithms the system attempts to identify and classify the lesion. The device is to be used by appropriately trained physicians to help facilitate early detection of melanoma. MelaFind recently received European CE Marking earlier this month.
The company plans to work closely with the FDA to finalize pending issues such as physician labeling, user’s guide, and clinical protocols for post-approval study to obtain the final go ahead to bring the device to market.
Press release: MELA Sciences Receives Approvable Letter From FDA for MelaFind(R)
Flashback: MelaFind Lesion Imaging Device Receives CE Marking
