TAG:
FDA
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…
Why Labs Should Comply with FDA’s Final Rule on LDTs
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
OIG Issues New Report on Medicare 2023 Lab Spend
CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such a…
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…
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…
November 25, 2024, Intelligence: Late-Breaking Lab News
Disruption is happening in the consumer genetic testing marketplace. In recent weeks, news outlets in the United Kingdom reported that Atlas Biomed, a consumer genetic testing company founded in 2016, had simply “disappeared.” Malwarebytes said Atlas Biomed’s “London offices …
129,624 Genetic Tests in the United States
REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administratio…
Two Different LDT Lawsuits Combined in Federal Court
CEO SUMMARY: Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern …
CURRENT ISSUE
Volume XXXII, No. 9 – June 23, 2025
In part one of an analysis about the state of AI in clinical laboratories, The Dark Report explores how frontline workers, especially younger ones, are using AI tools like ChatGPT far more than lab leaders. Recent reports elsewhere in the business world show executives underestimate staff AI use, raising concerns about a leadership gap in tech adoption. Clinical lab leaders must get more familiar with AI use cases. Also, in this issue of The Dark Report, there is discussion on how Medicaid cuts may affect clinical labs, an examination of the lab industry fallout from CLIAC termination, an analysis of AMP’s reports that provide crucial insights for Hiring Managers, and notes that regional health systems are new dominant players in M&A.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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