Medical Device and Diagnostic Industry (MD+DI)

Navigating IVD Regulations & Industry Challenges

IVDs are essential for disease detection, personalized treatment, and public health, driving growth in the global diagnostics ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
BioWorld

FDA finalizes IVD, medical device software guidance

The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health ...

iMDx Prepares for U.S. Commercial Launch of GraftAssureDx as Clinical Trial Nears Completion

GraftAssure™ technology adoption further broadens with 20 global transplant centers engaged by year-end 2025, including first Canadian ...
Seeking Alpha

Tempus Receives U.S. FDA 510(k) Clearance for Tempus xR IVD, its RNA NGS In Vitro Diagnostic Device

CHICAGO--(BUSINESS WIRE)-- Tempus AI, Inc. (TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) clearance from ...
Nasdaq

Tempus AI Enhances Cancer Research Tools With FDA-Cleared xR IVD

RNA sequencing provides a comprehensive view of biological information, offering deeper insights into disease mechanisms, including improved fusion detection. As a powerful tool in research and ...