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BioWorld - Sunday, May 22, 2022
Home » Authors » John Brosky

John Brosky

Articles

ARTICLES

EU sets high bar for clinical data required for every CE marked product

Oct. 26, 2017
By John Brosky
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Large-scale study to test software-assisted breast cancer screening

Oct. 19, 2017
By John Brosky
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CE mark reform shakes up authorized reps available for U.S. device makers

Oct. 18, 2017
By John Brosky
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BERLIN – The Medical Device Regulation (MDR) that reforms the European Union's (EU) rules for earning a CE mark have knocked out another leg of the stool that supports U.S. manufacturers. Already the number of Notified Bodies (NB) that grant the CE mark has been reduced from more than 80 to less than 60, and by 2019 that number is projected to drop to just 46 designated companies. (See BioWorld MedTech, April 19, 2017.)
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Radiologists challenge value-based model for health care reimbursement

Oct. 16, 2017
By John Brosky
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EU's medical device regs crashing down like a tsunami of paper work

Oct. 11, 2017
By John Brosky
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U.K. stepping back from lead role in implementing EU's Medical Device Regulation

Oct. 9, 2017
By John Brosky
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Coremedic wins funding to enter competition for mitral valve repair device

Sep. 19, 2017
By John Brosky
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Protembis following fast on path for embolic protection during TAVR

Sep. 7, 2017
By John Brosky
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PARIS – Protembis GmbH, based in Aachen, Germany, has begun the first-in-human trials for an intra-aortic filter that deflects away from the brain particles in the bloodstream set loose during transcatheter valve replacement (TAVR) procedures.
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Castle-AF hard data boosts trend of catheter ablation for atrial fibrillation

Aug. 30, 2017
By John Brosky
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Patients with atrial fibrillation (AF) can be treated with a drug or else a device through a catheter ablation procedure, and the trend toward the device got a strong boost with the results from the Castle AF clinical trial presented at the meeting of the European Society of Cardiology (ESC).
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Medtronic reports mitigated success treating hypertension with Spyral device

Aug. 29, 2017
By John Brosky
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One of the worst kept secrets at this year's meeting of the European Society of Cardiology (ESC) was confirmed when Dublin-based Medtronic plc confirmed positive outcomes for renal denervation in the treatment of moderate hypertension from the Spyral HTN-Off Med study during a Hot Line session.
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View All Articles by John Brosky

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