To ensure the quality and safety of medical services in primary healthcare institutions, China’s National Health Commission (NHC) and other relevant authorities issued a notice on 1 April 2026, outlining a three-year nationwide action.

Microplate-based automatic blood grouping analyzer Metis of Aikang MedTech Co., Ltd. (henceforth referred to as Aikang) received approval for marketing in 2015; and its MGT-based automatic blood grouping analyzer Aigel received approval for marketing in 2016.

Enable Biosciences said on Tuesday that it has received a $3 million Phase IIB Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases for its type 1 diabetes test.

The US Food and Drug Administration announced on Tuesday that it has approved AutoGenomics' test to determine whether a patient has an elevated risk of developing opioid use disorder (OUD).

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, has received 510(K) clearance from the U.S. Food and Drug Administration for its innovative Savanna PCR platform and Savanna HSV 1+2/VZV in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2) and Varicella-zoster virus (VZV) nucleic acids isolated and purified from swabs obtained from cutaneous or mucocutaneous lesion specimens obtained from symptomatic patients.

CACLP's initiative to launch an English/Chinese webinar for non-EU IVD players in next January is set to provide a crucial platform for understanding EU IVDR registration requirements.

Owkin announced on Tuesday that it entered into a collaboration with MSD — known as Merck in the US and Canada — to develop and commercialize microsatellite instability high (MSI-H) diagnostics for four types of cancer.

Significant regulatory changes across numerous medical fields are coming in 2024 with pharmaceutical and medical device companies urged to be ready for a year of legal alterations.

The immunoassay market has been the main driven force for the development of the in vitro diagnostics industry in recent years.

Euroimmun, a Revvity company, and Xpedite Diagnostics have partnered to offer DNA extraction protocols for point-of-care diagnostics.

Today, Illumina, Inc. (NASDAQ: ILMN) announced that the company will divest GRAIL.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.