TAG:
artificial intelligence
With LDT Rule Vacated, Labs Await FDA Retort
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…
Medical Robotics Developer Says It’s Time to Transform Phlebotomy
“Our innovation aims to make blood draws fully autonomous, safer, faster, more accurate, less painful, and more accessible.” —Brian Joseph, co-founder, Vitestro CEO SUMMARY: Phlebotomy and collection of veinous blood is one important procedure in clinical…
Upcoming Executive War College to Cover Important Lab Trends
New developments now changing the landscape in health-care and the clinical laboratory market will be addressed at the upcoming 30th Annual Executive War College on Diagnostic, Clinical Laboratory, and Pathology Management that happens on April 29-30, 20…
Quest Diagnostics, Labcorp Issue Q4 and Full Year 2024 Earnings
LAB ACQUISITIONS IN 2024 WERE A CONTRIBUTING FACTOR TO REVENUE GROWTH at the nation’s two biggest clinical laboratory companies. This was reflected in the fourth quarter and full year 2024 earnings reports issued by Labcorp and Quest Diagnostics. Here are recently …
Grim Realities Drive Payer Behavior with Lab Test Claims
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Mayo Clinic’s Ambitious Digital Pathology Initiative
CEO SUMMARY: It’s the latest example of an academic medical center moving to develop its own digital pathology solutions. This collaboration involves Mayo Clinic, Nvidia, and Aignostics. The three will work together to use digital pathology images and patient data from Mayo Clinic and C…
Pathologist Asks ChatGPT, Google Notebook to Predict LDT Trial Outcome
On his blog last month, pathologist Bruce Quinn, MD, PhD, published the answers provided by two artificial intelligence chatbots after he asked each to analyze the legal briefs submitted to federal courts in Texas where lab plaintiffs are challenging the FDA’s laboratory developed test (LDT) final …
Using AI to Predict Outcomes in FDA LDT Lawsuits
Given the popular sentiment that artificial intelligence (A…
Pathology Compensation in Different Settings, including Hospitals
CEO SUMMARY: This second installment on the series about boosting pathologist compensation uses data collected during a survey of 1,400 pathologists in 230 pathology practices by the Panel of National Pathology Leaders (PNPL). Two experienced pathology consultants identify the most effect…
Top 10 Lab Stories for 2024 Reflect Important Trends
CEO SUMMARY: Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with 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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