CE Mark given for Cepheid’s ‘plus’ COVID and flu diagnostic test 1
The Xpert Xpress CoV-2/Flu/RSV plus is a rapid diagnostic test for detecting the viruses causing COVID-19, Flu and respiratory syncytial virus (RSV).
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The plus version provides a third gene target for SARS-CoV-2 detection to deliver broader coverage.
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The test is designed for use on any of Cepheid’s GeneXpert Systems placed worldwide, with results delivered in approximately 36 minutes.
Henkel launches novel ‘healthcare’ 3D printing resins
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new class of 3D printing resins for healthcare applications expands Henkel’s Loctite brand. The broad portfolio of high-performance photopolymers offers a range of biocompatibility standards from safe-to-touch parts to medical devices. In addition to the established portfolio of Loctite 3D printing resins, the company innovates
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to deliver tailored formulations to fit the specific application requirements and market demands for optimised production. Recently, the Henkel 3D printing facilities in Concord (laboratory) and Dixon (production) in California, have achieved the ISO 13485:2016 certification for medical applications. Henkel 3D printing resins are designed and manufactured in accordance with ISO 13485 quality management standards to ensure uniformity in design, development, production, and delivery of medical devices. In Henkel’s case specifically, it covers the design and manufacturing of biocompatible resins and other materials used to produce non-implantable medical devices.
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Only one sample is required to run a single, highly sensitive multiplexed test that detects and differentiates all four viruses.
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Shipping to countries accepting CE-marked products began in October.
Argon Medical launches innovations for portal vein access procedures
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lobal manufacturer of specialty devices for interventional radiology, vascular surgery, and interventional cardiology Argon Medical Devices has launched two unique portal vein access sets intended for transjugular liver access in diagnostic and interventional procedures. The SCORPION Portal Vein Access Series addresses the common challenges physicians encounter when placing a transjugular intrahepatic portosystemic shunt or conducting other portal vein access procedures. The series includes Scorpion and ScorpionX, which offer improved visualization, revolutionary navigation control, and enhanced
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durability to augment existing procedural techniques. Using a patented curve-incurve system the series offers physicians 360° range of motion with the needle or stylet used to access the portal vein. Each curved component can work together or independently to accurately steer the device through the liver to the intended target. Existing systems utilize only a single curve limiting the steerability of the needle or stylet. The Scorpion Series’ novel design was created by Dr Lowell Kahn, a vascular and diagnostic interventional radiologist located in Springfield, MA, in conjunction with Hatch Medical.
