TAG:
whole slide imaging
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…
GE Healthcare Sells Omnyx to Inspirata
CEO SUMMARY: Now that the FDA has cleared a digital pathology for use in primary diagnosis, interest in DP is building. Inspirata purchased Omnyx and its assets because the Omnyx Dynamyx digital pathology software has strong features that could be integrated into Inspirata’s digital pat…
Top 10 Lab Stories of 2017 Dominated by Part B Cuts
CEO SUMMARY: In hindsight, 2017 is likely to be remembered as a milestone year that launched several disruptive developments that will reshape the lab industry moving forward. For the clinical laboratory sector this year, CMS confirmed its intent to slash Part B clinical laboratory test price…
TOP 10 LAB STORIES OF 2017
1. CMS Sticks by Decision to Deeply Cut Medicare Part B Lab Test Fees SHORT OF A MIRACLE, the clinical laboratory industry is less than three weeks from the single most financially-disruptive event of the past 30 years. On Jan. 1, the federal Centers for Medicare and Medicaid Service…
Digital Pathology Systems Will Create Opportunities
CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administra…
USC’s Clive Taylor, MD, Talks Digital Path, WSI
CEO SUMMARY: The FDA’s clearance of the first digital pathology system for use in primary diagnosis will be a disruptive force for pathologists in the coming years. At the University of Southern California Keck School of Medicine, pathologist Clive Taylor, MD, predicts that the benefits of …
Digital Pathology Can Be Transformative for Labs
CEO SUMMARY: Across the nation, pathologists are at a crossroads. Now that the FDA has cleared a digital pathology and whole slide imaging (WSI) system for use in primary diagnosis, should they adopt this technology sooner or wait until later? One pathologist who has worked with WSI for m…
Digital Pathology Systems Will Create Opportunities
CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administration for review of its whole slide imaging system. Following the FDA’s decision t…
Philips digital pathology system scores huge success as FDA clears digital path for primary diagnosis
This is an excerpt from a 1,400-word article in the April 24, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. …
Digital Pathology Makes Group More Competitive
CEO SUMMARY: One 15-member pathology group said adopting digital pathology will give it more competitive advantage. Advanced Pathology Associates (APA) in suburban Maryland, was one of four sites that participated in the clinical study of the Philips IntelliSite Pathology Solution applica…
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.
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.