clinical performance News
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Eurogin QIAGEN symposium
During the QIAGEN symposium at Eurogin the latest clinical performance and study data around Self-screen’s molecular screening and triage solutions were presented by excellent scientists. Topic 31 May 2021: Full molecular screening and triage solutions, chaired by Prof. dr. Chris Meijer Presenters: Dr. Bart Hesselink (Self-screen B.V., Netherlands) – Clinical performance of ...
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Haymarket Medical Education/myCME Earns Independent Certification
Haymarket Medical Education (HME)/myCME, a global leader in continuing medical education (CME), announced it has achieved independent certification for conformance to industry-established information security management guidelines and the BPA Worldwide standards for audience qualification, measurement and reporting from BPA Worldwide’s iCompli Technology Assurance division. HME/myCME ...
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myCME Launches myCME Live
myCME™, the leading provider of continuing medical education, is proud to announce the launch of myCME™ Live, a new program designed to increase attendance and engagement with live virtual and in-person meetings. Available for both single and multi-city/multi-date meetings, myCME Live leverages the myCME learning platform and Haymarket Medical Network’s broad reach of 2.2 ...
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SoCalBio Hosts a China Partnership Summit Featuring Proa Medical
Held on June 6 at the Jonathan Club in downtown Los Angeles, this summit honored a delegation from the City of Shenyang, Liaoning Province in Northern China, which was led by Shenyang 's Vice Mayor Kai Hunag. The Summit featured presentations by Southern California device and biotech companies -- including Proa Medical -- with interest in the fast growing Chinese market. SoCalBio is currently ...
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Showcase
Koning Begins FDA Clinical Screening Trial in Daytona Beach, Florida
DAYTONA BEACH, Fla., Nov. 1, 2021 /PRNewswire/ -- Koning begins an FDA screening trial this month for their no-compression, Isotropic, 3-dimensional breast imaging device. The company received FDA PMA approval for commercial, diagnostic use in 2017. Since then, the Koning Breast CT (KBCT) has been installed in clinics and universities in the US and globally. "This FDA screening trial is a major ...
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Molecular Health receives IVDR certification for MH Guide
Molecular Health, an international biotech IT company based in Heidelberg, Germany, has received European Union certification for its MH Guide clinical decision support software (SaaS) under the new In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR). The MH Guide software, which is used in molecular pathology laboratories, is the first of its kind in Europe to receive this certification. The ...
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The JRC releases new reference materials for the quality control of SARS-CoV-2 antibody tests
The JRC released two new reference materials, developed to function as quality assurance tools for the SARS-CoV-2 antibody tests used to verify if an individual has been infected by the COVID-19 virus. Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, said: "The correct functioning of antibody tests is particularly important in epidemiological investigations to ...
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Positive Clinical Results for Bluejay’s Symphony IL-6 Test Presented at AACC 2022
Demonstrated 98% NPV1 to Identify COVID-19 Patients at Risk for Severe Illness Study Data Indicate Symphony IL-6 Test Could be a Rapid and Precise Diagnostic Platform for Near-Patient Management of Critical Care Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical diagnostics company focused on developing cost-effective, rapid, ...
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Okami Medical Announces First Patients Treated With The LOBO Vascular Occluder
ALISO VIEJO, CA, March 5, 2020 — Okami Medical Inc., a medical device company, announced today the successful completion of the first cases with the LOBO™ Vascular Occlusion System. The first offering in the company’s product portfolio, LOBO-3, recently received 510(k) clearance from the U.S. Food and Drug Administration for the occlusion of peripheral arteries. The LOBO ...
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The Netherlands started QIAsure Methylation Test implementation trial for triage of HPV positively screened women
With the introduction of HPV based screening in 2017 the Dutch cervical cancer screening program underwent an important improvement. More women at risk are being discovered due to the higher sensitivity of HPV assays compared to the old cytology based test program, but as a consequence the number of referrals after cytology based triage of HPV positive women has increased 3 times. The ...
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Clinical investigations
We performed 2 clinical trials in leading neurorehabilitation hospitals in Germany and Spain proving safety, feasibility and usability of the exoskeleton in a clinical setting, and showing significant improvements in clinical outcomes and benefits in rehabilitation. A Multicentric Clinical investigation in Institut Guttmann (Spain) and Heidelberg University Hospital (Germany), leading European ...
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Dutch research institutions and Elsevier initiate world`s first national Open Science partnership
The Association of Universities in the Netherlands (VSNU), The Netherlands Federation of University Medical Centres (NFU), The Dutch Research Council (NWO) and Elsevier, a global leader in research publishing and information analytics, have formed a novel partnership that includes publishing and reading services as well as the joint development of new open science services for disseminating and ...
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Bluegrass Vascular Closes $5 Million Convertible Debt Financing
Privately held Bluegrass Vascular Technologies, a leading innovator and global manufacturer of lifesaving devices and methods based on the Inside-Out® vascular access procedure, today announced the closing of a $5.0 million financing in convertible promissory notes to a group of qualified investors, including new investors and existing shareholders who participated in previous capital raises. ...
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ASTM F2743 - 11 standard guide for coating inspection and acute particulate characterization of coated drug-eluting vascular stent systems
The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides guidance for coating inspection and acute particulate characterization of drug eluting ...
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Balt Completes Enrollment in FIRST: A Multi-center, Prospective, International Study of Low Profile Silk Vista Flow Diverters
Balt, an innovative neurovascular company focused on developing, designing, and manufacturing solutions for treating complex, life-threatening conditions, including stroke, aneurysms, and arteriovenous malformations, today announced enrollment in the FIRST study has been completed. The FIRST study is an observational, prospective, multi-center, international, single-arm study with the aim of ...
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Glycotest™ HCC Panel Completes Successful Clinical Product Evaluation
Glycotest Inc., announced today that it successfully completed a clinical evaluation of its HCC Panel in China. In a blinded evaluation of 149 HCC patient and control samples, the HCC Panel achieved an AUROC of 0.97. Glycotest is a private liver disease diagnostics company commercializing new and unique blood tests for liver cancers and fibrosis-cirrhosis. The Company’s mission is to ...
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A Reolution in TB Screening
World TB Day on March 24 will have particular significance for Cambridge-based Rapid Biosensor Systems (RBS). After an intensive six-year development programme, the company’s innovative TB Breathalyser will be in active use for the first time – delivering instant, reliable and cost-effective screening for early stage infection with tuberculosis at the point of care. Set to ...
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MicroVaccines SA has been officially incorporated as a spin-off of the IRB
MicroVaccines SA (from now on “MV”) has been officially incorporated in Canton Ticino on October 26th, 2018 as a spin-off of the Institute for Research in Biomedicine (from now on “IRB”) by Dr. Fabio Grassi, M.D., Ph.D. “This is an incredible achievement for a researcher and M.D., whose ambition is to translate experimental findings to medical application” ...
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Elsevier gives full access to its content on its COVID-19 Information Center for PubMed Central and other public health databases to accelerate fight against coronavirus
From today, Elsevier, a global leader in research publishing and information analytics specializing in science and health, is making all its research and data content on its COVID-19 Information Center available to PubMed Central, the archive of biomedical and lifescience at the US. National Institutes of Health’s National Library of Medicine, and other publicly funded repositories ...
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Magnolia Medical Appoints Industry Veteran, Joseph Bishop, as the Senior Vice President of Operations and Product Development
Magnolia Medical Technologies, Inc., inventors of Steripath, the only FDA 510(k)-cleared device platform indicated to reduce blood culture contamination for sepsis testing,1 today announced the addition of Joseph Bishop to the executive leadership team as Senior Vice President of Operations and Product Development. Mr. Bishop brings extensive and diverse medical device experience to Magnolia ...
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