TAG:
FDA Clearance
Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry
By Joseph Burns | From the Volume XXV No. 3 – February 12, 2018 Issue
“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.” …
Beckman Coulter Sues Quidel for Right to Sell BNP Assay
By Jon Stone | From the Volume XXV No. 1 – January 2, 2018 Issue
THERE IS AN INTERESTING COURT FIGHT UNFOLDING between Beckman Coulter Corporation and Quidel over the rights to sell a B-type natriuretic peptide (BNP) assay. The lawsuit is a consequence of Abbott Laboratories’ acquisition of Alere, Inc….
TOP 10 LAB STORIES OF 2017
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 Service…
Top 10 Lab Stories of 2017 Dominated by Part B Cuts
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 price…
FDA CLEARS WAIVED CBC FOR NEAR-PATIENT TESTING
By R. Lewis Dark | From the Volume XXIV No. 16 – November 20, 2017 Issue
CEO SUMMARY: Market clearance of the first-ever CLIA waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer …
FDA Clears Waived CBC For Near-Patient Testing
By R. Lewis Dark | From the Volume XXIV No. 16 – November 20, 2017 Issue
CEO SUMMARY: Market clearance of the first-ever CLIA-waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer Sysmex America, Inc., foresees…
September 18, 2017 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXIV No. 13 – September 18, 2017 Issue
Last week, 23andMe raised $250 million in a financing round led by Sequoia Capital. The company has an estimated value of $1.75 billion and has attracted $491 mill…
USC’s Clive Taylor, MD, Talks Digital Path, WSI
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 …
Philips digital pathology system scores huge success as FDA clears digital path for primary diagnosis
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. …
FDA Clears Digital Path for Primary Diagnosis
By Joseph Burns | From the Volume XXIV No. 6 – April 24, 2017 Issue
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…
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