TAG:
hematology analyzers
Two-Drop ‘Digital CBC’ Enters U.S. Market with FDA Clearance
“We believe the ability to work with just two drops of blood, plus the…
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…
Using Accurate Data to Grow Lab Outreach
CEO SUMMARY: In recent years, the laboratory outreach program at the Robert Wood Johnson University Hospital in New Brunswick, New Jersey, has achieved impressive rates of growth in specimen volume and net revenue. One reason for this success is that the lab outreach program moni…
Tour of Korean Labs Has Plenty to Teach
CEO SUMMARY: Faster turnaround times and better quality seem to be some common motivations for installing automation in the three Korean labs visited by THE DARK …
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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