In Vitro Diagnostic Scope For Medical Devices Articles & Analysis: Older
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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 supervision of Cairn Diagnostics. GEBT ...
A peer-reviewed journal has published the first research paper to state that the PrecivityAD™ blood test “can accurately identify brain amyloid status based on a single blood sample.” The research paper in Molecular Neurodegeneration adds that the test’s “excellent performance” for Alzheimer’s disease (AD) diagnosis allows for “improved medical ...
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. ...