Tag: cbc analyzer

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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FDA Clears Waived CBC For Near-Patient Testing

By Jon Stone, 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 its analyzer as a complement to central labs. Basic diagnostics would be

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Volume XXV No. 17 – December 3, 2018

DID CONGRESS JUST PASS A LAW that makes innocent labs guilty of criminal acts? At the last minute, Congress added all clinical laboratories to a far-reaching anti-kickback provision in the newly-enacted Support for Patients and Communities Act -- a provision that makes common practices such as paying commissions to sales staff or placing phlebotomists in labs could be illegal. Worse: The experts are baffled by the language of the new law. Notes one of these experts in this issue, "Someone in the clinical lab industry may have to get prosecuted before we get some clarity, unless the Secretary of HHS issues clarifying regulations."

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Tag: cbc analyzer

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