China has been engaged in the R&D and manufacturing of semi-automatic coagulation analyzers for over a decade, and based on the data from the website of the NMPA, in 2024 and 2025 (as od 15 August), a total of 2 instruments from 2 manufacturers have obtained registration certificates...

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

Zhejiang Orient Gene Biotech Co.,Ltd. invested US$5 million in Scotland, UK to establish a wholly-owned subsidiary ACCUBIO.LIMITED.UK. BGI Genomics Co.,Ltd. s IVD factory in Ethiopia has passed the Medical device-Quality management system-requirements for regulatory (ISO 13485:2016) .

FDA has granted another set of regulatory privileges under its breakthrough devices program. The latest batch is led by breakthrough designations for treatments of lung cancer and bone metastases that are in development at RefleXion Medical and Zetagen Therapeutics.

Scientists have for the first time obtained stem cells from livestock that grow under chemically defined conditions, paving the way for manufacturing cell cultured meat and breeding enhanced livestock.

Over the years, Mindray has brought tangible results and benefits to Africa through private cooperation, which is of great significance to local inclusive medical care and talent training.

The US Food and Drug Administration said on Friday that it has updated its website tracking the potential impact of SARS-CoV-2 variants on molecular diagnostic tests to include tests likely affected by the Omicron variant.

Just as convincing images of cats can be created using artificial intelligence, new proteins can now be made using similar tools. In a report in Nature, researchers describe the development of a neural network that “hallucinates” proteins with new, stable structures.

Euformatics said Friday that it has received a CE-IVD mark for its OmnomicsNGS variant interpretation and reporting software. The technology previously had CE marking as a Class I medical device under earlier European Union rules.

The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for an at-home sample collection kit for SARS-CoV-2 molecular testing developed by nonprofit digital health firm Audere.

Thermo Fisher Scientific held the unveiling ceremony of the first domestic gas chromatography-mass spectrometry in Suzhou factory. Runda announced that the new generation of clinical mass spectrometer - ARP-6465md triple quadrupole mass spectrometer system has been released.

To improve outcomes for patients with vascular disease, patients need accurate diagnoses and coordinated care early in their “patient journey,” Abbott concluded in its latest Beyond Intervention report.