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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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ACLA: Low Reimbursement Jeopardizes Monkeypox Lab Testing Effort

ACLA: Low Reimbursement Jeopardizes Monkeypox Lab Testing Effort

by Glenn S. Demby | Oct 19, 2022 | News, Open Content

Medicare Administrative Contractors are shortchanging labs on monkeypox test reimbursement, association says.

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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Abbott Scores First FDA Greenlight for Commercial Use of Monkeypox Test

Abbott Scores First FDA Greenlight for Commercial Use of Monkeypox Test

by Glenn S. Demby | Oct 17, 2022 | News, Open Content

Abbott’s Alinity m MPXV assay for detecting DNA from the monkeypox virus received FDA EUA on Oct. 7.

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