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Regulators worried that the device could give physicians a false sense of certainty, leading to fewer biopsies. Another concern was that doctors could misinterpret the device’s feedback, particularly error messages when a mole cannot be scanned. About 8 percent of growths scanned in the company study came back as “unevaluable.”

At a meeting last fall, FDA scientists said Mela Sciences had not shown how its device would influence day-to-day decisions by doctors. The agency also worried about its use by general doctors not accustomed to identifying suspicious skin moles. Despite these concerns, the panel of advisers narrowly backed the overall safety and efficacy of the device in a 8-7 vote.

Regulators said this week that they ultimately approved the device after Mela Sciences agreed to limit its use to board-certified dermatologists who undergo a specialized training course.

“The device is only good for certain lesions, and that’s why you have to be a dermatologist to be able to classify and categorize those lesions appropriately,” said Christy Foreman, director of FDA’s Office of Device Evaluation.

Foreman said an FDA-required follow-up study would help determine how much of a benefit MelaFind represents for patients.

“This device represents new technology. At the end of the day I don’t know that this will be the best technology out there, but it is a step forward to allow continued innovation in this area,” Foreman said.

Don’t expect to see a MelaFind machine at your next doctor’s appointment. The company plans to bring them next year to just 200 dermatologists on the East coast, all of whom must undergo company training before they can begin using the device.

Doctors will pay a one-time fee of $7,500 to lease and receive training on the device. Patients will pay $150 out of pocket for a MelaFind scan, which analysts say may limit use to more affluent patients who are willing to pay extra for the latest medical care. Mela Sciences does not plan to ask insurers to cover the device until several years from now, after it is more widely used.

Shares of the company fell 4 cents to $5.35 in afternoon trading.

Mela Sciences originally developed the technology to guide military weapons systems. But the company changed course in the mid-90s after consulting with dermatologists, adapting its technology for melanoma detection.


AP Chief Medical Writer Marilynn Marchione contributed to this report.