TAG:
FDA Clearance
News Briefs on Alzheimer’s Detection
FDA-cleared IVD could replace scans There has been a significant amount of activity in recent weeks as it concerns tests to detect Alzheimer’s disease. Clinical labs and neuropathologists will want to keep a cl…
FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says
This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…
HHS ‘Stands Down’ FDA on Its Oversight of LDTs
CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…
Expert Sees Pros, Cons In DP and WSI Systems
CEO SUMMARY: Now that the FDA has cleared two digital pathology systems for use in primary diagnosis, a growing number of pathology groups are taking up the question of whether and when they should adopt and use a digital pathology system and whole slide imaging. One pathologist with hand…
PGx Testing Labs Concerned by FDA’s Statements, Actions
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
Outside US, Digital Path Moves Ahead Rapidly
CEO SUMMARY: Implementation of digital pathology and whole-slide imaging systems in the United States lags behind that of other countries for two reasons. One is a more acute shortage of pathologists in those countries and the other is a less restrictive regulatory environment. In some lo…
FDA Clears Aperio’s Digital Pathology System
CEO SUMMARY: In May, the FDA announced clearance for Leica Biosystems to market its Aperio AT2 DX System for clinical diagnosis in the United States. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to pathologists reviewing and interpreting digital images of sur…
What’s Coming Next for Anatomic Pathologists?
INTERESTING THINGS ARE UNFOLDING within the profession of anatomic pathology. If the adage of “follow the money” applies to understanding why things happen, then recent events support some surprising conclusions. Take the news reported in this issue of The Dark Report that PathGroup …
April 29, 2019 Intelligence: Late Breaking Lab News
Investor interest in digital pathology (DP) and the use of artificial intelligence (AI) to analyze digital pathology images seems to be at a fever pitch recently. In the last three weeks, investors poured almost $85 million of capital into just three digital pathology companies, as noted below. This…
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?
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