The Food and Drug Administration has changed its mind on a device that scans skin lesions and can help detect melanoma -- the deadliest form of skin cancer -- with potentially over 98 percent accuracy, according to the company that makes the product.

Last week, the agency sent the Irvington, N.Y.-based Mela Sciences Inc. an "approvable letter" for the device, called MelaFind, the company said Tuesday. This means Mela Sciences has to work with regulators to come up with the final elements before approval, such as physician training tools and guidelines for a post-approval clinical study.

The news comes after Mela Sciences said it received European approval to sell the device earlier this month.

"Although melanoma is virtually 100 percent curable if detected at its earliest stage, one American dies from the disease every hour," Dr. Joseph V. Gulfo, president and CEO of the company, said in a statement. "We firmly believe that MelaFind has the potential to lower those tragic numbers."

Last year, the FDA rejected the device, saying a study commissioned by the company, and published in an Oct. 2010 issue of the Archives of Dermatology, failed to properly compare the device's readings with those from dermatologists, according to the Wall Street Journal. But this summer, during hearings about the FDA's approval process, the agency admitted it made a mistake in handling the company's application.

The device

The device is a two-part system: a hand-held imager attached to a computer. The imager scans skin lesions, and the information is fed to the computer, which uses classification algorithms trained on a proprietary database of more than 10,000 biopsied lesions to recommend whether the lesion should be biopsied or not.

In amendments to the device application recently filed by the company, it has agreed to limit the indications of use to dermatologists, or rather doctors trained in diagnosing skin cancers. Use of the device by physicians not trained in diagnosing melanomas was a concern of the FDA and an advisory panel it convened on the topic last November.

The device is also only indicated for scanning pigmented lesions that have some clinical indications of melanoma.

The company said the study used to support the device's application, involved 1,383 patients and 110 dermatologists. The device had a 98 percent sensitivity in finding melanoma, compared with the 80 percent sensitivity generally reported for human readers.