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Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition, covering the week of Nov. 3 - Nov. 9, includes trial data presented at the VIVA (Vascular InterVentional Advances) conference in Las Vegas, Nov. 5-8 as well as data from the initial experience with Medtronic's 34-mm CoreValve Evolut R TAVR system and the PARTNER IIA trial of Edwards' Sapien XT TAVR system.
Latest From Clinical Trials
Results Recap is Medtech Insight's exclusive summary of clinical trial results that have been announced or published in the past week, based on information collected by Meddevicetracker. This week's edition, covering the week of Nov. 9 - Nov. 15, includes trial data presented at the Veith symposium Nov. 13 - 17 in New York, the American Heart Association Scientific Sessions in Chicago Nov. 10 - 12, and the ObesityWeek meeting in Nashville Nov. 11 - 15.
US FDA is proposing to amend its regulations to allow an institutional review board to waive or alter informed consent when a clinical investigation "poses no more than minimal risk" to human subjects and includes safeguards to protect their rights and safety. See what agency head Scott Gottlieb said about it here.
On this week’s podcast, Reed Miller talks to Medtech Insight’s managing editor Marion Webb about digital health technologies of the future, showcased at the Exponential Medicine conference in San Diego, featured in depth in the latest Market Intelligence story. Medtech Insight’s deputy editor Reed Miller introduces Medtech Insight’s new “Tracking Trials” section, which features a list of trials that are starting, ending or finishing enrollment; including the “Results Recap,” a summary of trials that announced results. He also gives an update of key clinical trial news from this week’s American Heart Association meeting in Chicago.
The agency seeks input on the types of qualifying investigations that involve minimal risk. Providing informed consent waivers in these cases, as required by the 21st Century Cures Act, will help advance health-care innovations, FDA says.
Abbott Laboratories pointed to success in its electrophysiology device business last quarter, driven by multiple products including the Confirm Rx insertable cardiac arrhythmia monitor, which the firm says is the thinnest in class, and is smartphone-compatible for more direct patient engagement. See what Abbott VP Ari Fischer says about it here.
Promising new results from a pilot study of Abiomed’s Impella device to reduce damage after myocardial infarction sets the company up to start a pivotal study, which, if successful, could change how patients are treated immediately after an attack.
Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Nov. 5 through Nov. 11, including trial announcements from Medtronic, Evaheart, and VentureMed.
When ALung Technologies was selected in 2015 by US FDA to participate in the agency's Expedited Access Pathway program for its novel Hemolung device, the firm wasn't necessarily sure what it was getting itself into. See what ALung CEO Pete DeComo said about the pathway – now called the Breakthrough Devices Program – here.
Recently announced US National Evaluation System for health Technology "test cases" will be evaluated for up to a year by the NEST Coordinating Center after which collaborating device-makers may be in a better position to use real-world evidence to support new pre-market device submissions. The test cases will be measured, in part, based on their ability to identify brand-specific devices in the NEST Network Collaborators’ real-world datasets.
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