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FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously

By Ron Shinkman | May 27, 2026 | 1 min read

FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices

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RAPID coverage pathway may accelerate Medicare coverage determinations

FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests

By Ron Shinkman | Apr 14, 2026 | 1 min read

In both cases, the diagnostic tests report results back within 15 minutes

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NG Biotech and MeMed received breakthrough device designation

ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector

By Ron Shinkman | Mar 27, 2026 | 1 min read

But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort

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ADLM wants regulation of AI in the clinical lab sector

Agency Green Lights First SARS-CoV-2 Tests for Sample Pooling

By Glenn S. Demby | Aug 20, 2020 | 2 min read

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Agency Sounds the Warning on False-Positives from Becton Dickinson SARS-CoV-2 Reagents

By Glenn S. Demby | Aug 12, 2020 | 2 min read

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Agency Draws a New Line on SARS-CoV-2 Antibody Serology Tests

By Glenn S. Demby | Jun 8, 2020 | 2 min read

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Dozens of New COVID-19 Tests Get Emergency Clearance in April

By Glenn S. Demby | May 8, 2020 | 2 min read

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The FDA’s High-Stakes, High-Risk COVID-19 Serology Test Regulatory Strategy

By Glenn S. Demby | May 2, 2020 | 2 min read

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How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed

By Glenn S. Demby | Mar 24, 2020 | 2 min read

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Reimbursement: Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients

By Glenn S. Demby | Mar 17, 2020 | 2 min read

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Lab industry leaders meet with White House on COVID-19 testing

By Glenn S. Demby | Mar 8, 2020 | 2 min read

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Two commercial labs testing now for COVID-19

By Glenn S. Demby | Mar 8, 2020 | 2 min read

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FDA Watch: Agency Finalizes CLIA Waiver Guidance for New IV Devices

By Glenn S. Demby | Mar 6, 2020 | 2 min read

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