TAG:
FDA
Don’t Pass Up Chance to Steer LDTs, PAMA Reform
CLINICAL LABORATORY PROFESSIONALS HAVE RECEIVED A RARE CH…
LDT Oversight May Fall to Congress, CLIA
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
Enjoy the LDT Court Victory, Yet Remain Vigilant
VICTORY IN COURT! FOR AN INDU…
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…
In the Past, Labs Used Courts to Thwart Feds
CEO SUMMARY: A federal judge’s recent decision to vacate the FDA’s final rule on laboratory developed tests harkens back to a 2008 case where clinical labs stopped a CMS competitive bidding project. In the earlier case, legal risks led the government to back down. The …
White House Is Off to a Fast Start, So Pay Attention
We already see the second term of President Donald Trump…
Innovations in Lab Testing Arriving at Light Speed
TODAY, IT’S A CHALLENGE TO STAY UP WITH ALL THE NEW THINGS arriving in the lab testing marketplace. Novel assays are launched weekly. That is equally true for next-generation automation and lab analyzers, with vendors regularly announcing something new to their menu of products. The pace of innova…
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…
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.
The Dark Report
1000 N West Street, Suite 1200 Wilmington, Delaware, United States, 19801
Phone: 512-264-7103
Email: info@darkreport.com
© 2025 The Dark Report. All rights reserved. Part of the LabX Media Group