The US Food and Drug Administration (FDA) has set an “aggressive” timeline to implement generative artificial intelligence (genAI) across the agency by 30 June 2025.

Augurex Life Sciences Corp., a leader in autoimmune biomarker-based diagnostics, today announced that Health Canada has approved SPINEstat™, a first-in-class diagnostic blood test for axial spondyloarthritis (axSpA), as a Class II medical device. By detecting auto-antibodies to the 14-3-3eta protein, SPINEstat™ provides an important new clinically validated and objective biomarker to aid in the early and accurate diagnosis of axSpA.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Gastrointestinal Panel 2 Mini B for clinical use, further strengthening its syndromic testing portfolio in the United States.

BioMérieux announced Tuesday that its multiplex Biofire Spotfire Respiratory/Sore Throat Panel has received Health Canada approval.

Werfen today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Aptiva® Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) Reagents.

Lymphoma, also known as malignant lymphoma, is a general term for a group of malignant tumors originating from the lymphopoietic system. It is one of the most common tumors in China. In 2020, there were 544,352 new cases of non-Hodgkin lymphoma (NHL) worldwide, ranking 13th among all new cases of malignancies.

Health Canada has granted approval to MedMira’s Multiplo Rapid TP/HIV Test, for HIV and syphilis in Canada.

Devyser has achieved a significant regulatory milestone with its first market registration from China’s National Medical Products Administration (NMPA) for Devyser Compact, an IVDR-certified genetic test for detecting fetal chromosomal abnormalities. Rapid prenatal aneuploidy detection kits fall under Class III IVD as part of the NMPA product registration process. This approval enables Devyser to market Devyser Compact as an in vitro diagnostic in China and paves the way for future regulatory approvals in the region for its simple, fast, and accurate genetic testing solutions.

Sysmex Inostics said Tuesday that it has secured New York State Department of Health approval for clinical trial use of the firm's liquid biopsy assay for biomarkers that are relevant for the treatment of multiple cancer types.

The UK Medicines & Healthcare Products Regulatory Agency on Tuesday published a proposed framework for the recognition of in vitro diagnostics that have already been cleared in other jurisdictions.