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

On March 5, 2020, Amicus Therapeutics announced the official opening of its new Global Research and Gene Therapy Center of Excellence in Philadelphia, PA, to advance its portfolio of rare disease gene therapy programs. Amicus and the Univer

A new test being developed by Austin, TX-based Astrotech could detect coronavirus (COVID-19) and other lung diseases from the metabolites found in a persons breath. The companys BreathTest-1000 is a mass spectrometry technology that was ini

Thermo Fisher Scientific is bringing its diagnostic detects nucleic acid from SARS-CoV-2, the virus that causes COVID-19, to Europe. The Waltham, MA-based company said earlier today it had received CE mark for the test. The test uses Applie

Dear Colleagues, We are in a challenging time as the COVID-19 pandemic rapidly accelerates in New York City. Healthcare providers will need to make critical decisions that are far different than the normal practice of medicine and will like

Outpatient testing must not be encouraged, promoted or advertised. Persons with COVID-like illness not requiring hospitalization should be instructed to stay home. It is safer for the patients and health care workers and testing does not cu

Co-Diagnostics has been part of the coronavirus conversation for the past two months. Whether its been educating the public about the disease or developing diagnostics for the virus, the company has been at the forefront. Now the Salt Lake

Reorg Research reported that Medtronic is in early-stage acquisition talks withLivaNova, news that has been well received by LivaNova shareholders. The firm said Medtronic would subsequently break up LivaNova, keeping its neuromodulation bu

FDA is upping its response to address the novel coronavirus outbreak. The policy is aimed at laboratories seeking to develop diagnostic tests for the coronavirus. The policy allows laboratories to develop and begin to use the diagnostics be

Quest Diagnostics joins the growing number of firms that have developed tests for the coronavirus (COVID-19) in recent weeks.The Secaucus, NJ-based company said it was launching its COVID-19 test service that aids in the presumptive detecti

NEW YORK The US Food and Drug Administration on Friday granted Emergency Use Authorization to Luminex for the firms NxTag CoV Extended Panel to detect SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens. High-complexity molecula