A U.S. Food and Drug Administration advisory panel voted 8-7, with one panelist abstaining from the vote, to recommend approval for MelaFind, a pioneering skin cancer detection system.

The vote in favor of approving the device came as a surprise to some industry watchdogs, who predicted the General and Plastic Surgery Devices Committee would be opposed to recommending clearance for MelaFind after the release of FDA's briefing documents on the device before Thursday's meeting.

In its background documents, the agency said "the FDA review team has significant concerns that this device has not been studied adequately for its current indications for use and therefore puts the health of the public at risk," and that the data accompanying MelaFind did not demonstrate "any true clinical trade off and may potentially cause more harm than good to the health of the public."

The Irvington, N.Y.-based Mela Sciences, which manufactures the device, said in prepared remarks that the panel found that "for its proposed indications, MelaFind is safe and effective and that its benefits outweigh the risks."

Yet, some say the FDA, which makes the final decision on MelaFind's fate, may not consider the panel's split vote as an endorsement for approval.

When DOTmed News contacted Mela Sciences for a comment on whether or not it thinks the FDA will consider the split in the committee as a vote of confidence for the device, the company responded that it would not speak beyond the press release.

MelaFind is a hand-held device, designed to help physicians detect melanoma, the deadliest form of skin cancer. The device works by emitting 10 different wavelengths of light and acquiring images of skin lesions. It then runs the images through an extensive database of lesion images to offer a recommendation on a potential biopsy for melanoma.

The FDA is yet to indicate when it would make a decision regarding the approval of the device, according to Mela Sciences.

The committee reviewed two main clinical trials by the company, which involved approximately 1,400 patients with lesions.

Following the panel's decision, the company's stock price doubled overnight. The shares shot up 105.5 percent to $5.24 before the markets opened.

Mid-day Friday, the company's stock sold for $4.84 per share.

More Industry Headlines