Diagnostics Pipeline: FDA Approves Visby Medical’s Over-The-Counter Women’s Sexual Health Test
It’s the first PCR-based sexually transmitted infection test platform for at-home use
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Diagnostics Pipeline: 2024 Trends in FDA Approvals
In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests
Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
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Agency Temporarily Allows Modifications of Influenza and RSV Tests Without Premarket Notification
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FDA Pulls the Plug on EUA Review of Laboratory Developed Tests for COVID-19
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Agency to Provide Emergency Clearance for Multi-Analyte Respiratory Panels
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HHS Clears the Way for Use of New COVID-19 Tests without FDA Emergency Use Authorization
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FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests
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First Enforcement Action for Improper Marketing of SARS-CoV-2 Antibody Tests
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