Doctors in the coming months are likely to have a new tool to diagnose the deadly skin cancer melanoma, after the Food and Drug Administration reversed its earlier decision and said the MelaFind device was “approvable,” pending some final negotiations.
The FDA cleared the path for approval in a letter it sent to Mela Sciences Inc. Thursday night. The letter hasn’t previously been disclosed.
The device is intended to help identify melanoma in a systematic way. A special camera captures an image of a lesion, and a computer then analyzes it using an algorithm developed on thousands of patients.
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