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

Novacyt on Monday reported a nearly 15 percent year-over-year decrease in revenues for the first half of 2021 as the French diagnostics firm held off on including revenues generated under a disputed SARS-CoV-2 test supply contract with the UK Department of Health and Social Care.

Beckman Coulter Life Sciences said on Monday that it has entered into an agreement with Invitae to develop applications for Beckman's new next-generation sequencing library preparation system.

On September 23, FDA sent a letter to all manufacturers that received EUA authorization for COVID-19 tests, urgently notifies all these manufacturers of three new requirements for their EUA-authorized tests.

GE (NYSE:GE) has entered into an agreement to acquire BK Medical, a leader in advanced surgical visualization, from Altaris Capital Partners for a cash purchase price of $1.45 billion.

On September 26, Hangzhou Matridx Biotechnology Co., Ltd. (hereinafter referred to as Matridx) announced that it had completed a strategic investment of hundreds of millions of yuan.

Lucid Diagnostics on Thursday announced a proposed initial public offering of its common stock.

Zymo Research announced on Thursday that its EZ DNA Methylation-Lightning Kit has received CE marking.

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (“Mindray”) (300760.SZ), a leading global provider of medical devices and solutions, has completed its previously announced acquisition of HyTest Invest Oy and its subsidiaries (“HyTest”), a global leading provider of antibodies and antigens.

The agency is requiring test developers to monitor emerging mutations and their potential impact on the performance of authorized SARS-CoV-2 tests.

Investigators have determined that high-risk HPV DNA can be detected in saliva in most patients with HPV-driven oropharyngeal cancers at the time of diagnosis.