Tag: FDA Clearance

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 locations outside the United States, pathologists have adopted fully-digital operations,

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What’s Coming Next for Anatomic Pathologists?

INTERESTING THINGS ARE UNFOLDING within the profession of anatomic pathology. If the adage of “follow the money” applies to understanding why things happen, then recent events support some surprising conclusions.

Take the news reported in this issue of The Dark Report that PathGroup of Nashville is acquiring Pathologists Bio-Medical Laboratories (PBML) of Dallas. That brings together two regional

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Georgia Micro Lab Slashes TAT by Almost Two Days

CEO SUMMARY: Two projects to boost the performance of the microbiology laboratory at University Health Services in Augusta, Ga., significantly reduced test turnaround times in ways that contributed to improved patient outcomes. The first project was in 2016, when the lab introduced mass spectrometry and MALDI-TOF for bacterial infections, cutting turnaround times from 104 to

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Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry

“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.”

—Ralph Taylor, President, Sysmex America, Inc.

CEO Summary: To bring testing closer to patients, clinical laboratories will need to offer sophisticated point-of-care systems

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Beckman Coulter Sues Quidel for Right to Sell BNP Assay

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., last fall.

With that acquisition, Abbott Laboratories became the world’s largest manufacturer of point-of-care (POCT) lab tests. But federal anti-trust

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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 prices aggressively, effective Jan. 1. For the anatomic pathology sector

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FDA CLEARS WAIVED CBC FOR NEAR-PATIENT TESTING

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 its analyzer as a complement to central labs. Basic diagnostics would

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