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- WSJ's Tom Burton has the exclusive story of the FDA approving the MelaFind device, a new method for detecting and diagnosing melanoma, the deadliest form of skin cancer.
- Melanoma is the most lethal form of skin cancer, but it accounts for less than 5% of all skin-cancer cases, according to the American Cancer Society.
- Studies suggest the typical dermatologist might be right about 80% of the time in diagnosing melanoma lesions, according to New York University dermatologist Darrell S. Rigel, who helped create current diagnostic methods and is a Mela Sciences consultant.
- The "approvable" letter the FDA sent to Mela Sciences last week negates the need for an additional study.
- The agency said at the time that the Irvington, N.Y., company needed to conduct a large new study because the one published in October 2010 didn't adequately compare the device findings with those of dermatologists
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