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FDA

Former Theranos Lab Director Makes News at Elizabeth Holmes Trial

This is an excerpt of a 1,867-word article in the October 18, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: During the trial, a pathologist who was a former Theranos lab director testified about the little…

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Pathologist Makes News at Elizabeth Holmes Trial

CEO SUMMARY: During the trial, a pathologist who formerly was CLIA lab director at Theranos testified about the little regard Theranos executives had for federal proficiency testing regulations labs must follow to retain their CLIA license. Another point of contention was how this p…

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Artificial Intelligence: Coming at Light Speed!

YOU HAVE PROBABLY  NOTICED THAT THE TERM “ARTIFICIAL INTELLIGENCE” is now part of the description for a growing proportion of the new products and services being offered to your clinical laboratory or anatomic pathology group. Regardless of whether it is automation, analyzers, or software, the claim…

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First Digital Path AI Tool Cleared for Market by FDA

CEO SUMMARY: In a first for the anatomic pathology profession, the Food and Drug Administration (FDA) has cleared for market a digital pathology image analysis product intended to aid pathologists in the diagnosis of prostate cancer. Developed by New York City-based Paige, the Paige…

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Paige’s Digital AI Tool Aids in Prostate Cancer Diagnosis

CEO SUMMARY: Study data provided to the FDA “demonstrated increased diagnostic accuracy” when pathologists used the Paige Prostate system, said Paige’s Medical Director. The artificial intelligence-powered pathology image analysis tool is trained to help pathologists detect ev…

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Digital Pathology Image Service Delivers AI via the Internet

IN GERMANY, AN EMERGING DIGITAL PATHOLOGY (DP) COMPANY has introduced a novel feature that could be a low-cost way for pathology groups to access artificial intelligence (AI) for digital image analysis. This would appeal to pathologists who may be reluctant to invest the substantial cost and time req…

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Executive War College to Show New Opportunities for Labs

CEO SUMMARY: Yes, the pandemic continues and hospitals are running short of beds in many communities. At the same time, 225 million Americans are either vaccinated or have some immunity to COVID-19. Based on the early registrations to attend the 27th annual Executive War College, it…

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New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings

CEO SUMMARY: Our second installment in this series describes an emerging new clas…

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PathAI Buys Poplar Health, Creates Unique Company

CEO SUMMARY: Pathologists were surprised this summer when a company developing image analysis software announced the acquisition of one of the nation’s largest independent anatomic pathology (AP) laboratories. The technology company PathAI is now the owner of Poplar Healthcare Man…

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NeoGenomics Acquires Inivata to Access Liquid Biopsy Technology

SOME BELIEVE THAT LIQUID BIOPSY TECHNOLOGY has the potential to develop into a Holy Grail of cancer diagnostics. Yet progress in this field has been slow. Now a recent lab acquisition may accelerate the development of clinically-useful liquid biopsies. There is keen interest in how to achieve the …

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