vitro diagnostic medical device News
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Waters ACQUITY UPLC I-Class/Xevo TQ-S micro System available as a U.S. FDA Class I, CE-Marked Medical Device
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). This development allows clinical laboratories to access leading innovations in liquid chromatography (LC) and mass spectrometry (MS) technology for the ...
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Peer-Reviewed Journal Publishes PrecivityAD™ Blood Test Research, Confirming Its Role in Assisting Clinicians in Alzheimer’s Diagnosis
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 ...
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Cairn Diagnostics Delivers Virtual Administration of its Novel 13C-Spirulina Gastric Emptying Breath Test
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 ...
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BSI extends healthcare rReach with Eurocat acquisition
BSI, the global standards and assessment body, has acquired German healthcare certification and testing business, EUROCAT. This development significantly enhances BSI’s ability to service the medical device market globally.EUROCAT is an established Notified Body offering healthcare systems and product certification. The company has a significant presence in Germany - the third largest medical ...
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Sonic Incytes Selected for MedTech Innovator Asia Pacific Accelerator
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 organization’s Asia Pacific Accelerator program. Each of the ...
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