TAG:
Food and Drug Administration
Assessing the Clinical Service & Revenue Issues of the LDT Rule
BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…
Fitting Pathology AI Firms into DP Market Puzzle
CEO SUMMARY: Today, the best-known developers of AI-based algorithms have been in business almost 10 years. During that time, there has been continuous improvement in the digital technologies used in digital scanning and digital image analysis. Despite these improvements, many pathology g…
Uncertainty in Market for Digital Path Products
CEO SUMMARY: These are uncertain times for many companies offering a range of digital pathology (DP) products to the nation’s pathologists. Sales lag behind projections that caused investors to pour money into numerous DP start-ups. One reason DP companies are not meeting sales goals is…
Unpacking the Surprises in the FDA LDT Rule
THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALL…
September 3, 2024, Intelligence: Late-Breaking Lab News
To challenge the federal Food and Drug Administration (FDA) final rule on laboratory developed tests (LDTs,) the Association for Molecular Pathology (AMP) filed a lawsuit on August 20, 2024, in the United States District Court for the Southern District of Tex…
August 12, 2024, Intelligence: Late-Breaking Lab News
In recent years, many of the national retail pharmacy chain operators announced big plans to open primary care clinics. Now, after substantial investments of billions of dollars, those same retail pharmacy chains are unwinding these business lines. This spring, Walmart announced it w…
What’s a Big Headwind for Labs? It’s the LDT Rule!
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Language in Draft House Bill Directs FDA to Suspend LDT Rule
THERE IS AN INTERESTING NEW DEVELOPMENT associated with the regulation of laboratory deve…
What Labs with LDTs Must Do to Comply with FDA’s LDT Rule
CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…
Clarapath Automates Slide Prep, Microtomy Workflow
>>CEO SUMMARY: Histology is one area of laboÂratory medicine that utilizes a mostly manual work flow. However, pathology labs will soon have a novel solution designed to automate many of the steps in microtomy that produce glass slides. Reduced variability in the finished glass s…
CURRENT ISSUE
Volume XXXI, No. 12 – September 3, 2024
This special intelligence briefing—presented in three parts—identifies the factors retarding a faster adoption of digital pathology. Also, how to protect your lab’s proprietary LDTs and assess the financial impact of compliance.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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