TAG:
WSI
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…
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…
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…
For Top 20 Tests, CMS to Cut Payment by 28% in 2018-2020
ON SEPT. 22, MEDICARE OFFICIALS RELEASED THE DRAFT PRICES for the 2018 Clinical Laboratory Fee Schedule. The bad news for the lab industry is that the fee cuts are deeper than the federal Centers for Medicare and Medicaid Services had predicted earlier. The price cuts to clinical la…
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…
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…
FDA Clears Digital Path for Primary Diagnosis
CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone on April 12 when the FDA cleared the Philips digital pathology system for sale in the United States. Now pathologists can use the system to perform primary diagnoses and get paid for those pr…
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.
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