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

BioMérieux said on Friday that it has received 510(k) clearance from the US Food and Drug Administration for its Vitek MS Prime MALDI-TOF mass spectrometry identification system.

The US Food and Drug Administration last week granted separate Emergency Use Authorizations for two SARS-CoV-2 antigen tests developed by Siemens Healthineers.

On March 17th, NMPA has approved the 14th New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) produced by Zybio. Up to now, 14 COVID-19 antigen detection kits have been approved for sale.

Eurofins Viracor said on Thursday that it has acquired an exclusive license to a sequencing-based liquid biopsy technology developed at Cornell University for tracking tissue damage in COVID-19 and transplant patients.

Foundation Medicine said on Thursday that the US Food and Drug Administration has approved its FoundationOne CDx test as a companion diagnostic to identify non-small cell lung cancer patients with EGFR exon 19 deletions or exon 21 alterations for treatment with EGFR inhibitors.

Cue Health said on Wednesday that it has received interim order authorization from Health Canada to sell its at-home molecular COVID-19 self-test in that country.

DiaSorin on Wednesday said that its 2021 revenues rose 41 percent year over year.

On March 16, PHASE Scientific’s INDICAID COVID-19 Rapid Antigen At-Home Test get EUA issued by the US FDA.

Joinstar’s COVID-19 Antigen Rapid Test (Colloidal Gold) anterior nasal-self testing device, was awarded the CE certificate issued by EU.

Illumina said on Tuesday that it has received CE-IVD marking for its TruSight Oncology Comprehensive (EU) assay this month.