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Virus Resurgence Means More Need For Tests

 
• By Brian Bossetta

With COVID-19 infection rates on the rise again throughout much of the US, device manufacturers are trying to answer the need for more tests.

COVID-19 TESTING SIGN.
• Source: Alamy

When it seemed just a few months ago the US was turning the corner on the COVID-19 pandemic, the need for tests diminished as more Americans got vaccinated and a glimmer of light appeared at the end of the tunnel. But turns out that light was the oncoming Delta variant.

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Medtech Seeks Inclusion In EU’s Groundbreaking Life Sciences Strategy

 
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‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
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More from Policy & Regulation

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• By Elizabeth Orr

Former FDA Commissioner Robert Califf urged the Heart Rhythm Society to engage actively amid federal funding cuts. He highlighted collaboration among researchers, advocates for healthcare integration, and the importance of addressing social determinants of health, while discussing lobbying strategies and the challenges faced by medtech companies.

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 
• By Brian Bossetta

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‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
• By Natasha Barrow

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.