Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to ...

The U.S. district judge’s decision, issued on March 31, 2025, vacated the May 2024 final rule through which FDA sought to ...

defined as in vitro diagnostics (IVD) products – as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Filed by the American Clinical Laboratory Association (ACLA), member ...

The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.

Billion CAGR (2024-2030): 3.65% Market Segmentation: Reagent Type, Technology, Application, End-users, and Geography ...

Bringing in vitro diagnostic (IVD) products to market in the United States requires more than technological innovation and scientific validation. Manufacturers must navigate an ever-changing ...

In July 2024, the Guardant Health Shield test, a blood-based CRC screening test, was approved by the FDA as a primary screening ... diagnosing CRC via in vitro diagnostics (IVD) tests is necessary ...

The Food and Drug Administration (FDA) announced Thursday it plans to phase out animal testing requirements for biological products and drugs, instead moving toward alternative testing models such ...

In addition, regulatory agencies like the FDA in the U.S. have been instrumental in fostering the growth of the IVD market by providing clear guidelines and fast-tracking approvals for new ...

oncoReveal ® CDx has been FDA cleared on the Illumina MiSeq ™ Dx. The oncoReveal ® CDx IVD is reported to payers using the Proprietary Laboratory Analysis CPT code 0523U. "Next generation ...