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Analyst, Bullish on Mela, Misquotes FDA

Shuren testified on July 20, 2011 as part of a congressional hearing into medical device regulation. A video of the hearing can be found here. Shuren's remarks about MelaFind referenced above can be found starting at the 3-hour 13-minute mark of the hearing.

MelaFind is a computer-enhanced imaging device that takes high-tech pictures of suspect moles and lesions to assist doctors in the early detection of melanoma, the deadliest form of skin cancer.

FDA rejected MelaFind in March 2010. Mela appealed the FDA decision and demanded the agency convene an advisory panel to review the device. The FDA agreed and a panel was held in November 2010, which voted 8-7 to recommend the approval of MelaFind despite the strenuous objections of the FDA's medical device review staff.

FDA reviewers sharply criticized the accuracy of MelaFind's skin-cancer detection results. FDA reviewers have also raised concerns about the potential for misdiagnosis of skin cancer that could result if MelaFind were used incorrectly.

Since the advisory panel, Mela has amended and resubmitted the MelaFind approval application, trying to satisfy FDA's concerns. The company has also tried to pressure the FDA politically and legally to approve MelaFind but to date, U.S. regulators have issued no decision on the device.

Mela shares were down 27 cents, or 8%, to $2.97 in Monday trading.

--Written by Adam Feuerstein in Boston.



>To contact the writer of this article, click here: Adam Feuerstein.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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