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
FDA-dtet
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
Evolving Regulations and Guidelines in Genetic Testing
Understanding the regulatory landscape of genetic and genomic testing, and its impact on clinical practice
FDA Approves First-Ever, Pan-Cancer Drug in Milestone for Personalized Medicine
From - Diagnostic Testing & Emerging Technologies
In what is being heralded a major milestone for personalized medicine, in late May the U.S. Food and Drug Administration (FDA) approved the first…
FDA Reclassifies Rapid Flu Antigen Tests
From - Diagnostic Testing & Emerging Technologies
Effective mid-February the U.S. Food and Drug Administration (FDA) is reclassifying antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used…
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