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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.)
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.
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).
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.
BEIJING – China will kickstart a phase III trial Feb. 3 to determine whether patients with 2019-nCoV can be treated with Gilead Sciences Inc.’s NUC inhibitor,...
HONG KONG – In another example that communication is proving as difficult as containment in the current coronavirus outbreak, China’s state media reported, to...
SEATTLE – Tracing the family tree of COVID-19 through its evolving DNA sequence makes it possible to disprove many false claims circulating on social media about...
HONG KONG – A team of researchers at Hong Kong University of Science and Technology (HKUST) claim to have invented the world’s fastest portable 2019-nCoV...
New analysis from Clarivate Analytics' Cortellis Forecast Team predicts 11 medicines set to enter the market in 2020 will reach more than $1 billion in sales by...
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