Vitro Diagnostic Medical Device Articles & Analysis
6 news found
Cairn Diagnostics, an innovative leader in providing cutting-edge breath tests intended for routine use in diagnostic medicine, today announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of the Company’s 13C-Spirulina Gastric Emptying Breath Test (GEBT) to now include “at home” administration under virtual ...
MedTech Innovator, the largest accelerator of medical device companies in the world, in partnership with Asia Pacific Medical Technology Association (APACMed), the first and only regional association to provide a unified voice for the medical technology industry, today announced the 20 companies selected to participate in the ...
We know there’s an urgent need for non-invasive and easily available diagnostic tools that identify Alzheimer’s pathology,” says Dr. ...
Waters Corporation (NYSE: WAT) today announced that the Waters® ACQUITY UPLC® I-Class IVD/Xevo® TQ-S micro IVD System is now manufactured as a U.S. FDA Class I medical device and is CE Marked to the European Directive 98/79/EC (IVDD). ...
BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, is rapidly implementing plans to expand its medical device Notified Body scope to include in vitro diagnostic (IVD) devices. ...
EUROCAT also has a growing customer base in Russia and Turkey.EUROCAT is accredited by all relevant bodies for the certification of medical devices, in-vitro diagnostics and active implantable devices, and is renowned for ensuring a high level of customer confidence in its services. Product testing and CE ...