Seven years after it was initially submitted, the PMA for MelaFind, a noninvasive diagnostic scanner for detecting melanoma made by Mela Sciences, was approved by FDA. The agency sent the company an approvable letter in late September, and approval was finalized in November.

Mela Sciences’ troubles navigating the FDA review process were highlighted in a Fortune magazine article from September titled, “Is the FDA Killing Innovation?” According to the article, CDRH director Jeffrey Shuren acknowledged to Congress that FDA had erred by not initially referring the PMA for the device to an advisory committee. The article described the effort FDA was making to paint the case as an outlier.

“In the early going,” the article reads, “the company worked so closely with [FDA] that they negotiated a rare, binding agreement to set the terms for the product’s path through the review process.” A month before a recent congressional hearing on the matter, Mela Sciences filed a petition accusing the center of multiple abrogations of that agreement. The company has now withdrawn the petition based on the device’s final approval.

MelaFind carries the following labeled indication, as printed in a release:

“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. MelaFind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should not be used to confirm a clinical diagnosis of melanoma.”

According to the release, MelaFind’s use is restricted to “physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training in the appropriate use of MelaFind.”