On January 5, the US Food and Drug Administration (FDA) issued a new draft Guidance on Investigational IVDs Used in Clinical Investigations of Therapeutic Products. Based on concerns that drug ...

On July 31, 2014, the U.S. Food and Drug Administration ("FDA") announced plans to regulate laboratory developed tests ("LDTs"). In this Client Alert, we explore FDA's proposed regulatory framework ...

Every person who has received blood test results or been treated in a hospital has benefited from in vitro diagnostic testing. The prevalence of these tests and their direct influence on the next ...

Join us in a timely two-day event on advancing diagnostic immunoassay technology and performance. During this Virtual IVD Conference, March 16-17, 2021, starting at 8:00am EDT, we will be discussing ...

Bruker Corporation (NASDAQ: BRKR) today announced that it has received clearance from the China Food and Drug Administration (CFDA) to market and sell its IVD MALDI Biotyper System as a medical device ...

Making an in vitro diagnostic assay has never been easy. Now with the global lab and supply chain and disruptions caused by the COVID pandemic, the development and manufacture of IVDs faces further ...

MINNEAPOLIS, March 23, 2021 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ:TECH) today announced that Exosome Diagnostics, a Bio-Techne brand, has completed its clinical validation of an in vitro ...

Of its many wiles, one of the biggest impacts that the pandemic has had on society is that it forced much of the world into an existential crisis. Ever since COVID-19 made its debut, people from ...

CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific today launched the CE-IVD marked Ion Torrent Genexus Dx Integrated Sequencer, an automated, next-generation sequencing (NGS) platform that ...

SAN DIEGO, Aug. 3, 2017 /PRNewswire/ -- Opioid addiction and other drugs of abuse, blood poisoning and crippling diseases driving up healthcare costs and threatening outcomes, were problems taken on ...

Beckman Coulter Life Sciences unveils its expanding clinical flow cytometry portfolio at the 69th American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Laboratory ...

DUBAI, United Arab Emirates, June 30, 2017 /PRNewswire/ -- Thousands of medical laboratory industry experts and equipment suppliers from across Northern and Latin America will be converging at the ...