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Regulators scanning the digital scanners

A recent panel on whole-slide imaging launched a clear message from the Food and Drug Administration: The agency views WSI systems as Class III medical devices and plans to regulate them as such. Gentlemen, start your turtles.

While the FDA’s decision was clear, the next steps are anything but. Vendors, pathologists, the FDA, and the Centers for Medicare and Medicaid Services could head in any number of directions next, but they won’t be moving swiftly. In fact, those who were at the meeting are still dissecting the information presented at the panel, as if Alan Greenspan had delivered one of his famously tortured pronouncements from the Federal Reserve. [more]