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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 | Essential, 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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December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance

December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance

by Glenn S. Demby | Nov 21, 2022 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.

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FDA Watch: Monkeypox, COVID-19, and MDD Tests

FDA Watch: Monkeypox, COVID-19, and MDD Tests

by Glenn S. Demby | Oct 31, 2022 | Essential, FDA-lir, Laboratory Industry Report

While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.

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November 2022 FDA Watch: Pace of New Approvals Slows

November 2022 FDA Watch: Pace of New Approvals Slows

by Glenn S. Demby | Oct 18, 2022 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

Though there were fewer new approvals last month, the impact of the products that did gain approval more than made up for the drop in volume.

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Abbott Ushers Monkeypox Testing into Its New Commercial Phase

Abbott Ushers Monkeypox Testing into Its New Commercial Phase

by Glenn S. Demby | Oct 18, 2022 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

Abbott has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.

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