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

Wondfo Biology Co., Ltd., and Shenzhen Tisenc Medical Device Co., Ltd., a domestic chemiluminescence enterprise, have signed an agreement to acquire 100% equity and corresponding interests of Tisenc medical.

As a "visa" for products to enter the European market, CE certification is a mandatory requirement for product access in the EU market. From May 26, 2022, the European Union will begin to implement the In Vitro Diagnostic Medical Device Regulation EU 2017/746 (IVDR).

The US Food and Drug Administration said on Wednesday that it will consider Emergency Use Authorization submissions for SARS-CoV-2 variant genotyping assays.

Quest Diagnostics said on Tuesday that it has acquired substantially all of the assets of LabTech Diagnostics.

On December 14, Beijing Hotgen Biotech Co., Ltd. announced that the company intends to acquire 38.0993% equity interest in Oriomics by way of equity transfer and subscription of additional registered capital at a price of CNY 153 million.

In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report.

Canadian precision medicine lab services provider CellCarta has acquired Belgian genomic testing solutions firm Biogazelle. Financial terms of the acquisition were not disclosed.

Fluorescence light microscopy has the unique ability to observe cellular processes over a scale that bridges four orders of magnitude. Yet, its application to living cells is fundamentally limited by the very rapid and unceasing movement of molecules that define its living state.

Baxter International Inc. (NYSE:BAX), a global medtech leader, announced today it has completed its acquisition of Hillrom. Baxter paid $156.00 in cash for each outstanding share of Hillrom common stock for a purchase price of $10.5 billion (based on Hillrom share counts at closing).

Recently, Autobio's thyroid functional magnetic particle chemiluminescence series reagents obtained the EU IVDR CE certification issued by TüV SüD. This is the first series of Autobio’s products to obtain the EU IVDR CE certification.