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

Rapid test maker Hangzhou Clongene Biotech and diagnostics product distributor Gold Colloid on Friday said they inked a deal to distribute Clongene's in vitro­ diagnostics products in the US.

Rapid diagnostic tests for dengue fever will be accessible at all airports across the country starting Friday, the Korea Disease Control and Prevention Agency (KDCA) said, Thursday. This comes in response to the rising number of domestic cases, where individuals have been contracting the virus through mosquito bites during their overseas travels.

A menstrual pad designed with a removable strip to collect blood samples for clinical tests has been granted clearance by the US Food and Drug Administration (FDA).

US-based Veracyte has agreed to acquire minimal residual disease (MRD) test developer C2i genomics in a deal worth up to $95m, strengthening its range of cancer diagnostic products.

The UK government on Tuesday said it has issued legislation for the implementation of new regulations governing in vitro diagnostics and medical devices.

The total number of first-time registrations of Class II and III medical devices in 2023 was 14,942, a decrease of 129 registrations compared with that of 2022.

Illumina, Natera, CareDx, MDxHealth, and Revvity were among the molecular diagnostics and genomics tools firms reporting preliminary financial results on Monday evening or Tuesday morning.

GE HealthCare (Nasdaq: GEHC) today announced it has entered into an agreement to acquire MIM Software, a global provider of medical imaging analysis and artificial intelligence (AI) solutions for the practice of radiation oncology, molecular radiotherapy, diagnostic imaging, and urology at imaging centers, hospitals, specialty clinics, and research organizations worldwide. GE HealthCare expects to leverage MIM Software’s imaging analytics and digital workflow capabilities across various care areas to accelerate innovation and differentiate its solutions for the benefit of patients and healthcare systems around the world.

Chemiluminescence immunoassay reagent has become the mainstream product in the field of immunoassay and is widely used in clinical in vitro diagnosis due to its advantages such as high sensitivity, good specificity, a wide range of measurements, high degree of supporting automation, and excellent precision and accuracy.

Devyser Diagnostics AB has entered an in vitro diagnostic development agreement with Illumina, Inc. (Nasdaq: ILMN). The agreement enables Devyser to develop and offer its in vitro diagnostic (IVD) tests on Illumina MiSeqDx next-generation sequencing (NGS) instrument in the United States and Europe.