CAP Today: Regulators scanning the digital scanners

Of the FDA’s decision to regulate whole-slide imaging systems as Class III devices, Aperio president Dirk Soenksen says, “They’ve made up their mind.... You’re talking five years at the earliest when someone’s going to get approval.” How broad will Aperio's submission be? “As broad as FDA allows,” he says.

Hi y'all.  You're probably familiar with CAP Today already - it's a great publication for anyone interested in Pathology, and it's available free online - but today's new issue has great article about the FDA panel discussion held at Pathology Visions in October: 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.

Depending on one’s view, the news will slow efforts to bring WSI for primary diagnosis into U.S. laboratories, with some vendors looking to Europe for regulatory relief; have virtually no impact on large vendors, who, while not necessarily enamored of the FDA’s decision, concede it’s one they can live with; kill the market completely; choke innovation among vendors, especially component makers; possibly put laboratories in jeopardy if they try to validate these systems as laboratory-developed tests under CLIA; or encourage laboratories to use WSI for other, already approved purposes, readying themselves for the inevitable day when whole-slide imaging transforms surgical pathology.

It's an interesting article, please check it out.  Among other things it makes the point that while regulators and industry leaders debate the future of digital pathology for primary diagnosis, the technology is in active use today for many other clinical applications, such as QA, secondary consultations, and image analysis.