Mela Sciences (MELA) said U.S. regulators have approved its skin cancer detection device MelaFind, possibly innovating the way the deadliest cancer is detected.
The device, which Dr. Darrell Rigel, a professor of dermatology at New York University Medical School, called “groundbreaking technology,” represents one of the most significant advances in early melanoma detection. The disease is responsible for 75% of skin cancer fatalities.
"While there have been incremental improvements in imaging tools for melanoma detection, we still primarily rely on our eyes, experience and judgment," Rigel said, noting that MelaFind provides information about pigmented skin lesions to help determine whether to biopsy.
The company plans to launch MelaFind in “high volume” dermatology and skin cancer specialists’ practices in the Northeast during the first quarter of next year.
Mela has been trying to get the device approved by the Food and Drug Administration since June 2009, and even filed a citizen’s petition with the agency earlier this year in an effort to address the reasons for the delay in the approval process. With the final approval, though, the company said it has withdrawn the petition.
In September, Mela Sciences received approval in the European Union. Along with its rollout in the U.S., the company plans to undertake a similar launch of the device in Germany.
MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma.
The device, which uses a special dermoscope to view the skin through a thin layer of alcohol or oil, is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. It can’t be used to confirm a clinical diagnosis of melanoma.