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Diagnostic Testing and Emerging Technologies

LAB COMPLIANCE ADVISOR

LABORATORY INDUSTRY REPORT

NATIONAL LAB REPORTER

FDA Watch: 2022 510(k) Lab Test Approvals Year in Review

FDA Watch: 2022 510(k) Lab Test Approvals Year in Review

by Glenn S. Demby | Jan 31, 2023 | FDA-lir, Laboratory Industry Report

Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.

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Roche Alzheimer’s Early Detection Tests Get FDA Green Light

Roche Alzheimer’s Early Detection Tests Get FDA Green Light

by Glenn S. Demby | Dec 22, 2022 | Diagnostic Testing and Emerging Technologies, FDA-dtet

In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.

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December 2022 FDA Watch: More Approvals in US than EU

December 2022 FDA Watch: More Approvals in US than EU

by Glenn S. Demby | Dec 1, 2022 | FDA-lir, Laboratory Industry Report

A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.

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Illumina Faces Loss of Grail, Massive Fines

Illumina Faces Loss of Grail, Massive Fines

by Glenn S. Demby | Aug 2, 2022 | News

European Commission accuses sequencing giant of “jumping the gun” on Grail acquisition.

New EU IV Diagnostic Regulation Takes Effect on May 26

New EU IV Diagnostic Regulation Takes Effect on May 26

by Glenn S. Demby | May 5, 2022 | Articles, News, Open Content

While the much-delayed IVDR will take effect at the end of the month, it will be rolled out gradually.

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