TAG:
digital pathology
CLIA on Path to Recognize Lab Data As a Specimen
By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue
CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …
Eight Macro Trends for Clinical Labs in 2023
By Robert Michel | From the Volume XXX, No. 1 – January 3, 2023 Issue
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
Getting the Jump on Solving Major Lab Issues
By R. Lewis Dark | From the Volume XXIX, No. 14 – October 10, 2022 Issue
Observant laboratory managers and pathologists will note a recurring theme among the business intelligence briefings in this issue of The Dark Report: Solutions to major challenges require proactive steps. A case in point comes…
October 10, 2022 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXIX, No. 14 – October 10, 2022 Issue
Future regulation of laboratory-developed tests (LDTs) may not be as clear as it once appeared. On Sept. 30, Congress passed a short-term resolution to keep the federal government funded. As part of the move, a proposed bill to increase oversight of LDTs has been sidelined, at least for now, accordin…
Shortage of Pathologists a Factor in Adoption of Digital Pathology
By Robert Michel | From the Volume XXIX, No. 12 – August 29, 2022 Issue
WITHIN THE UNITED STATES, it is now recognized that the demand for surgical pathologists exceeds the available supply. There are more vacant positions than qualified applicants to fill them. The question yet to be answered is when this shortage of patho…
Sonic Healthcare Acquires ProPath, PathGroup Buys Path Consultants
By Robert Michel | From the Volume XXIX, No. 2 – January 31, 2022 Issue
CONSOLIDATION AMONG PRIVATE PRACTICE ANATOMIC PATHOLOGY GROUPS continues with news that two large regional pathology groups decided to sell to larger pathology companies. The first transaction announced was on Dec. 16, 2021, when Sonic Healthcare …
Artificial Intelligence: Coming at Light Speed!
By R. Lewis Dark | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
YOU HAVE PROBABLY NOTICED THAT THE TERM “ARTIFICIAL INTELLIGENCE” is now part of the description for a growing proportion of the new products and services being offered to your clinical laboratory or anatomic pathology group. Regardless of whether it is automation, analyzers, or software, the claim…
First Digital Path AI Tool Cleared for Market by FDA
By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
CEO SUMMARY: In a first for the anatomic pathology profession, the Food and Drug Administration (FDA) has cleared for market a digital pathology image analysis product intended to aid pathologists in the diagnosis of prostate cancer. Developed by New York City-based Paige, the Paige…
Paige’s Digital AI Tool Aids in Prostate Cancer Diagnosis
By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
CEO SUMMARY: Study data provided to the FDA “demonstrated increased diagnostic accuracy” when pathologists used the Paige Prostate system, said Paige’s Medical Director. The artificial intelligence-powered pathology image analysis tool is trained to help pathologists detect ev…
Digital Pathology Image Service Delivers AI via the Internet
By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
IN GERMANY, AN EMERGING DIGITAL PATHOLOGY (DP) COMPANY has introduced a novel feature that could be a low-cost way for pathology groups to access artificial intelligence (AI) for digital image analysis. This would appeal to pathologists who may be reluctant to invest the substantial cost and time req…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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