Tag: laboratories

Proposed Bill in Congress Would Regulate LDTs

CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for

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Philips digital pathology system scores huge success as FDA clears digital path for primary diagnosis

This is an excerpt from a 1,400-word article in the April 24, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone

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Digital Pathology Makes Group More Competitive

CEO SUMMARY: One 15-member pathology group said adopting digital pathology will give it more competitive advantage. Advanced Pathology Associates (APA) in suburban Maryland, was one of four sites that participated in the clinical study of the Philips IntelliSite Pathology Solution application for FDA clearance to use the system for primary diagnosis. The experience was of

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