Melafind, New Melanoma-Diagnosing Tool, Receives FDA Approval
- Posted on: Nov 10 2011
Huge news in skin cancer treatment: Melafind, a device to help diagnose early melanoma, was recently approved by the FDA and will be on the market soon. Up until now, the best technique to diagnose melanoma, short of surgical biopsy, has been the clinical examination. Melafind gives dermatologists objective information about questionable lesions in order to help them decide which lesions should be biopsied. According to an article in MSNBC:
The company submitted its PMA application to the FDA in June 2009. The studies used to support the PMA application for MelaFind were the 1,383-patient U.S. pivotal trial and the pivotal trial’s companion reader study of 110 dermatologists. The device demonstrated a 98% sensitivity in the pivotal trial, and a similar sensitivity in the reader study compared to a 72% sensitivity for participating dermatologists.
Melanoma is the most dangerous form of skin cancer, killing one American every hour. Early detection is definitely a big key to the survivability of this terrible disease. I applaud the manufacturer (MELA Sciences), researchers, and subjects for helping potentially save thousands of lives.
For more information, click here for the MSNBC.com article.
Tagged with: biopsy, Melafind, melanoma, skin cancer
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