In Vitro Diagnostic Medical Device Articles & Analysis
4 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 ...
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. ...