Issue: Volume XXVIII, No. 13 - September 27, 2021

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

This is an excerpt of a 3,644-word article in the September 27, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Our second installment in this series describes an emerging new class of in vitro diagnostics (IVD) companies. These companies have analyzers and …

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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 is that artificial intelligence (AI) is integral to the …

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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 Prostate system was determined by the FDA to improve diagnostic accuracy …

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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 even small areas of cancer in biopsied prostatic tissue on digital images thus improving accuracy, a significant development given …

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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 required to acquire and implement image scanners and …

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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 appears vaccinated individuals are ready to travel to a …

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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 class of in vitro diagnostics (IVD) companies. These companies have analyzers and tests designed specifically to be simple to run, generate results in minutes, use small sample sizes, and cost less than even high-volume routine tests run in core labs. These new IVD competitors …

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MedPAC Reports to Congress on Issues in Lab Test Price Survey

IN THE HALLS OF CONGRESS, A GOOD NEWS/BAD NEWS STORY is unfolding around the multi-year cuts to the prices Medicare pays for clinical laboratory tests. First the good news.  In its latest semi-annual report to Congress, the Medicare Payment Advisory Commission (MedPAC) confirms much of what the clinical laboratory industry has been saying about Medicare’s new lab test payment …

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September 27, 2021 Intelligence: Late-Breaking Lab News

Following the opening of her criminal trial in a Silicon Valley courtroom in recent weeks, Elizabeth Holmes—the disgraced ex-Founder and CEO of Theranos—continues to be the subject of news headlines. Federal prosecutors are calling witnesses to testify. Much of this testimony includes anecodotes and facts about her personal life and the way she made business …

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