TAG:
Food and Drug Administration
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…
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…
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…
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…
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…
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…
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…
Insurers Get Aggressive with Years-Old Audits, Searching for Lab Overpayments
This is an excerpt of a 1,971-word article in the July 26, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Not only are health insurers looking back to find lab overpayments and funds paid erroneously, but…
Insurers Get Aggressive with Years-Old Audits
CEO SUMMARY: Not only are health insurers looking back to find overpayments and funds paid erroneously, but payers also are requiring documentation for overpayments. If clinical labs and anatomic pathology groups do not appeal such claims quickly, they may be liable for any amount i…
Genetic Testing Continues to Grow in Volume and Complexity
This is an excerpt of a 1,333-word article in the July 26, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Getting paid for genetic testing continues to be a challenge. This is true for both payers and the…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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