The US Food and Drug Administration (FDA) has updated and expanded its list of premarket medical device consensus standards that include important topics such as medical device cybersecurity, ...

WALTHAM, Mass.--(BUSINESS WIRE)--Revvity, Inc. (NYSE: RVTY), today announced the launch of three Mimix™ reference standards for IVD use, designed for monitoring of next-generation sequencing (NGS) or ...

A new draft guidance document issued by the US Food and Drug Administration (FDA) seeks to establish a framework for the use of voluntary consensus standards in medical device premarket submissions.

In vitro diagnostics (IVDs) are a mainstay of modern medicine. People of all ages and their healthcare providers rely on these tests to determine the risk of a wide range of chronic and acute diseases ...

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...

The Waters ACQUITY™ UPLC™ I-Class/Xevo™ TQD IVD System enables the quantification of organic compounds in human biological liquid matrices. This article demonstrates the system’s analytical ...

EPALINGES, Switzerland--(BUSINESS WIRE)--Abionic, an emerging medical diagnostics company focused on rapid early detection technologies, announced today that its IVD CAPSULE PSP test has received ...

Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows “Accurate diagnosis, including ...