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

Released in conjunction with National Patient Safety Awareness week, ECRI InstitutesTop 10 Patient Safety Concerns for 2020raises the profile of safety issues that pose risks to patients and healthcare providers. The report relies on the an

FDA Halts Foreign Inspections In a rare action that is sure to impact medical device application reviews, FDA suspended inspections outside the United States through April in response to the coronavirus pandemic. The decision was based on g

Tests for the coronavirus (COVID-19) continue to roll in as the U.S. faces a public health crisis. Thermo Fisher Scientific and Mayo Clinic are the latest with diagnostic contributions. Waltham, MA-based Thermo Fisher is the second company

BD (Becton, Dickinson and Company) was one of several medtech companies that joined President Donald Trump when he declared a national emergency last week. Several medtech executives detailed their response to the novel coronavirus (COVID-1

Oncocyte said it has completed Clinical Laboratory Improvements Amendments (CLIA) validation for its DetermaIO. The Irvine, CA-based company said the diagnostic, which was previously known as the Insight Genetics IM Score Test, is used in l

FDA issued a letter to industry that includes steps the agencysCenter for Devices and Radiological Health (CDRH) has taken to prioritize work that advances the nations response during the Coronavirus (COVID-19) public health emergency. The

NEW YORK A new UK-based research consortium is betting that sequencing the virus that causes COVID-19 can provide policymakers with a clearer picture of the spread of the epidemic across the country as diagnostic testing remains limited. I

NEW YORK Pangolins may be an intermediary host for SARS-CoV-2, the virus causing the ongoing COVID-19 pandemic, a new sequencing analysis has found. While bats are thought to be the likely reservoir of SARS-CoV-2, experts suspect another ho

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