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

NEW YORK Oncocyte said after the close of the market on Wednesday that its fourth quarter net loss rose 77 percent year over year as it pushed toward a transition to commercial test operations. For the three-month period ended Dec. 31, 2019

NEW YORK Biocept said after the close of the market on Wednesday that its fourth quarter revenues more than doubled year over year, driven by 46 percent growth in commercial test volume and 34 percent growth in average insurance reimburseme

NEW YORK HTG Molecular Diagnostics reported after the close of the market on Wednesday an 11 percent year-over-year drop in its full-year revenues, driven by a significant decrease in collaboration revenue. For the year ended Dec. 31, 2019,

FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially redu

NEW YORK Quidel said after the close of the market on Wednesday that it has received expanded Emergency Use Authorization from the US Food and Drug Administration for the Lyra SARS-CoV-2 assay. Under the expanded EUA, the assay can now be u

Novartis announced in a March 20, 2020 press release that it is committing to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine and a related drug, chloroquine,

FDA announced that the agency will temporarily postpone all domestic routine surveillance facility inspections, those conducted every few years based on a risk analysis. In a March 18, 2020 statement, FDA Commissioner Stephen M. Hahn said t

Abbott Laboratories, one of the biggest players in the medical device space, has obtained Emergency Use Authorization for a test to detect the coronavirus [COVID-19]. The Abbott Park, IL-based company joins the rapidly expanding list of com

The Association of the British Pharmaceutical Industry (ABPI) has issued a statement noting that it shares the ambition of the United Kingdoms government, as set out in its published approach to the negotiations for the future relationship

Swift Biosciences has partnered with LGC Biosearch Technologies to incorporate Swift's targeted sequencing technology into LGC's kits and service offerings for the worldwide ag-bio market.