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New NHS England Processes To Tackle Uncertainties And Delays In Setting Up Clinical Trial Sites
A new "standard charging methodology" is to be introduced across NHS England to allow drug and device clinical trials to get underway faster. Presently, there can be a difference of up to nine months between confirmations being issued by each NHS hospital taking part in a multi-site trial.
Clinical Trials
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Latest From Clinical Trials
QUOTED. May 18, 2018. William Abraham.
Results of a study showed that Impulse Dynamics' Optimizer device significantly improved exercise tolerance and quality of life in certain heart-failure patients. See what principal investigator (and cardiologist) William Abraham of Ohio State University said about those patients here.
HRS 2018: Optimizer Cardiac Contractility Device Helps Subset Of Heart-Failure Patients
The FIX-HF-5C trial, a subgroup study derived from the FIX-HF-5 pivotal trial, shows that the Impulse Dynamics Optimizer cardiac contractility modulation device significantly improved exercise tolerance and quality of life in certain heart-failure patients. Results of the trial were presented at the Heart Rhythm Society conference in Boston. Impulse Dynamics expects to file the final PMA module for US FDA for Optimizer in June.
iSTAR's Glaucoma Micro Device Shines In Early Follow-Up
iSTAR Medical reported six-month clinical trial data supporting its latest micro-invasive glaucoma surgery device, MINIject.
New Technology
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Latest From Innovation
iSTAR's Glaucoma Micro Device Shines In Early Follow-Up
iSTAR Medical reported six-month clinical trial data supporting its latest micro-invasive glaucoma surgery device, MINIject.
Starts & Stops: May 7-13, 2018
Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements made between May 7 and 13, 2018, including announcements from BioCardia, Akili Interactive Labs, Arch Therapeutics, and Acutus Medical.
Global Device Approvals, Weekly Snapshot: May 7-13, 2018
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
Approvals
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Latest From Approvals
QUOTED. May 18, 2018. William Abraham.
Results of a study showed that Impulse Dynamics' Optimizer device significantly improved exercise tolerance and quality of life in certain heart-failure patients. See what principal investigator (and cardiologist) William Abraham of Ohio State University said about those patients here.
HRS 2018: Optimizer Cardiac Contractility Device Helps Subset Of Heart-Failure Patients
The FIX-HF-5C trial, a subgroup study derived from the FIX-HF-5 pivotal trial, shows that the Impulse Dynamics Optimizer cardiac contractility modulation device significantly improved exercise tolerance and quality of life in certain heart-failure patients. Results of the trial were presented at the Heart Rhythm Society conference in Boston. Impulse Dynamics expects to file the final PMA module for US FDA for Optimizer in June.
BTG Heads To Panel Next Month For Emphysema Device
A PMA for the PneumRx ELEVAIR endobronchial coil system will be considered by a US FDA advisory panel in June, but there will likely be some questions about the data.
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