MelaFind Gets FDA Approval For Detecting Melanoma

September 29, 2011
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This has been a long haul for Melafind as back in November of 2010 the FDA panel approved the device, and here we are in September of 2011 with now jut getting approval.  Below is a video from the Wall Street Journal that depicts some of the history on Melafind. 

This has been a long haul for Melafind as back in November of 2010 the FDA panel approved the device, and here we are in September of 2011 with now jut getting approval.  Below is a video from the Wall Street Journal that depicts some of the history on Melafind. 

New Melanoma Identification Device Gets FDA Panel Approval–Questions About How Human Intervention Works with Melafind Algorithm Arise From Discussion

In August 27, 2009 I reported that the device company was waiting approval so here with even my blog you have a bit of history. 

MelaFind Medical Device for Detecting Melanoma Skin Cancer Awaiting FDA Decision

We all know early detection with melanoma is key.  The FDA letter of approval from the FDA indicates that labeling and use is still being worked on before the product is out on the market, but it’s coming.  The device recently received the European CE mark of approval as well.  BD 

IRVINGTON, NY, Sep 26, 2011 (MARKETWIRE via COMTEX) — MELA Sciences MELA -0.81% today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter for the MelaFind(R) Pre-Market Approval (PMA) application. The company intends to work with the agency to finalize the physician and patient labeling, package insert, user’s guide, training program and clinical protocol for a post-approval study in order to obtain final approval.

“The FDA’s Approvable Letter for MelaFind represents a monumental milestone for MELA Sciences and the millions of Americans who are at risk of developing melanoma, the deadliest form of skin cancer,” said Joseph V. Gulfo, MD, President and CEO, MELA Sciences. “The company has worked tirelessly to develop an objective tool to help dermatologists detect melanoma at its earliest, most curable stages. Although melanoma is virtually 100% curable if detected at its earliest stage, one American dies from the disease every hour. We firmly believe that MelaFind has the potential to lower those tragic numbers. We are extremely pleased with the FDA’s decision and will work diligently to answer all open questions and finalize the post-market study protocol in the coming weeks.”

The Approvable Letter from the FDA comes on the heels of the CE Mark for MelaFind issued earlier this month. CE Mark approval allows MelaFind to be sold across the 27 nations of the European Union.

http://www.marketwatch.com/story/mela-sciences-receives-approvable-letter-from-fda-for-melafindr-2011-09-26

 

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