in vitro diagnostic medical 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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The state drug administration issued five medical devices regulations
Recently the state food and drug supervision and administration bureau released five related medical devices regulations come into force as of June this year to the new revision of the regulations on the supervision and administration of medical devices, authorized by the state administration of the in-depth research, many times, on the basis of demonstration, solicit opinions from all sides, and ...
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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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Robocath successfully completes first robotic coronary angioplasty with R-One in China
Robocath, a company that designs, develops and commercializes innovative robotic platforms for the treatment of vascular diseases, today announces the successful completion of the first coronary angioplasty in China assisted by its R-One™ robotic platform. The procedure took place at the 301 Hospital in Beijing on November 24; performed by Dr. Yundai Chen, a renowned interventional ...
By Robocath
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Robocath’s joint venture, Cathbot, concludes first clinical study in China to evaluate robotic PCI safety and efficacy
End of study brings Robocath closer to commercializing R-One in China in 2023 149 patients enrolled over six months in four Chinese centers Results of first vascular robotics study on this scale in China will be published in March 2023 Robocath, a company that designs, develops and commercializes innovative robotic platforms for the treatment of vascular diseases, announces today that ...
By Robocath
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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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