Medical technology company MELA Sciences Inc. recently announced that its pre-market approval (PMA) for MelaFind will undergo review by the General and Plastic Surgery Devices Panel appointed by the U.S. Food and Drug Administration (FDA) on August 26, 2010.
As the deadliest form of skin cancer, melanoma is responsible for roughly 80 percent of skin cancer fatalities, and melanoma rates continue to increase with an estimated 120,000 new cases projected in 2010. There is no cure for advanced-stage melanoma, which makes early detection vital for recovery.
MelaFind is the company’s hand-held imaging device that emits multiple wavelengths of light to capture images of suspicious pigmented skin lesions and extract data, serving as a tool for early detection.
“We are so pleased to see the MelaFind review process move forward,” Joseph V. Gulfo, MD, president and CEO stated in the press release. “We and our advisors look forward to the Panel meeting with great anticipation. We have had positive and constructive interactions with the agency culminating in the submission of our formal response to the FDA’s questions regarding the PMA application earlier this month. We are now fully focused on preparing for the August 26th panel meeting and firmly believe that MelaFind will be found to be a valuable tool to help dermatologists detect melanoma at the earliest, most curable stage.”
MELA said it received a letter from the FDA on March 19, 2010. The letter included several questions regarding the MelaFind PMA application, and ultimately stated that the application was not approvable at that time. The review process was extended for up to 180 days from the company’s submission of the response to the FDA action letter.
In April MELA submitted a draft response and held an in-person meeting with the FDA to review and clarify questions in the initial letter from the FDA. The company submitted the final formal response to the FDA on May 7, 2010.
For more information visit www.melasciences.com
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