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Diagnostic Testing and Emerging Technologies

LAB COMPLIANCE ADVISOR

LABORATORY INDUSTRY REPORT

NATIONAL LAB REPORTER

M&A & Strategic Deals: Dealmaking Shows New Signs of Life but FTC Scrutiny Casts a Dark Shadow

M&A & Strategic Deals: Dealmaking Shows New Signs of Life but FTC Scrutiny Casts a Dark Shadow

by Glenn S. Demby | Jun 1, 2023 | Industry Buzz-lir, Laboratory Industry Report

After a significant lull, M&As in the lab diagnostics space heated up in May, with several key deals announced.

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The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations

The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations

by Glenn S. Demby | Apr 24, 2023 | Diagnostic Testing and Emerging Technologies, FDA-dtet

On March 27, the agency released a new guidance document to help test developers make the transition to full approval.

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Clinical Lab Services Market to Be Worth More than $125.6 Billion by 2030

Clinical Lab Services Market to Be Worth More than $125.6 Billion by 2030

by Rachel Muenz | Mar 15, 2023 | News

A recently released report estimates that the US market will grow at a CAGR of 4.2 percent over the next seven years.

New Breakthrough Device Designations Fall 37 Percent in 2022

New Breakthrough Device Designations Fall 37 Percent in 2022

by Glenn S. Demby | Feb 22, 2023 | Diagnostic Testing and Emerging Technologies, FDA-dtet

According to the FDA’s recently-released annual report, only 135 devices received the designation last year, versus 213 in 2021.

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The 2022 Year in FDA 510(k) Approvals

The 2022 Year in FDA 510(k) Approvals

by Glenn S. Demby | Feb 1, 2023 | News

Roche and Abbott received the most approvals for new lab tests last year.

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