By Joseph Burns, from the Volume XXVI No. 10 – July 22, 2019 issue
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 surgical pathology slides prepared from formalin-fixed paraffin
By Joseph Burns, from the Volume XXV No. 3 – February 12, 2018 issue
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 pathology solution. In this interview with THE DARK REPORT, Inspirata CEO
By Robert Michel, from the Volume XXIV, No. 17 – December 11, 2017 issue
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 Services will impose deep cuts to Part B
By Robert Michel, from the Volume XXIV, No. 17 – December 11, 2017 issue
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 prices aggressively, effective Jan. 1. For the anatomic pathology sector
By judeb, from the Volume XXIV, No. 7 – May 15, 2017 issue
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 to clear this system for sale earlier this month, and informed by their
By Joseph Burns, from the Volume XXIV, No. 10 – July 17, 2017 issue
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 whole slide imaging and digital pathology will enable pathologists
By Joseph Burns, from the Volume XXIV, No. 9 – June 26, 2017 issue
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 many years shared the lessons learned in
By Robert Michel, from the Volume XXIV, No. 7 – May 15, 2017 issue
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 to clear this system for sale earlier this month, and informed by their
By Mary Van Doren, from the Volume XXIV, No. 6 – April 24, 2017 issue
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.
CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone
By Joseph Burns, from the Volume XXIV, No. 6 – April 24, 2017 issue
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 application for FDA clearance to use the system for primary diagnosis. The experience was of
