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Clinical / R & D

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ACC Results Recap Part II: CardioMEMS Post-Approval Trial Shows Monitoring Reduces Heart-Failure Hospitalizations; Medtronic’s Tyrx Envelope Reduces Infections

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the second of three Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including clinical trial data on devices from Abbott Laboratories, Medtronic, Medi-Lynx, and iRhythm. See Part 1 of our ACC Results Recap for more on the groundbreaking trials of transcatheter aortic valve replacement in low-risk patients and the Apple Heart study of Apple Watch's ability to track atrial fibrillation.

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Clinical Trials

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Latest From Clinical Trials

Results Recap: EndoBarrier Improves Obesity And Diabetes Outcomes In UK Study; Procept’s Aquablation Proves Effective Again

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition covers new clinical data released March 8 to March 22, not including the data presented at the annual conferences of the American Academy of Orthopedic Surgeons or American College of Cardiology, which are presented in separate special editions of Results Recap.

Tracking Trials Clinical Trials

Device Week, March 22, 2019 – Goings-On At US FDA

In this week’s podcast, senior reporters Elizabeth Orr and Ferdous Al-Faruque give a quick rundown of FDA goings-on the device industry should keep a sharp eye on, including a reorganization of the Center for Devices and Radiological Health, remarks from outgoing agency head Scott Gottlieb on laboratory developed tests, and news from a recent FDA neurological devices advisory panel meeting.

Device Week FDA

Neuro Devices Panel Skeptical On Alzheimer’s Treatment

The US FDA neurological devices panel on March 21 found significant faults with Neuronix’s de novo application for its neuroAD Alzheimer’s treatment system. A key concern was that the device missed its primary endpoint in the pivotal trial.

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New Technology

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Latest From Innovation

Results Recap: EndoBarrier Improves Obesity And Diabetes Outcomes In UK Study; Procept’s Aquablation Proves Effective Again

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition covers new clinical data released March 8 to March 22, not including the data presented at the annual conferences of the American Academy of Orthopedic Surgeons or American College of Cardiology, which are presented in separate special editions of Results Recap.

Tracking Trials Clinical Trials

UK Champions Oxfordshire As Next Global Digital Health Hub

The UK government is championing the region of Oxfordshire to become the next global digital health hub post-Brexit. The ambitious plans to develop the UK’s digital health technologies were outlined at a recent event at the House of Commons in London.

United Kingdom Artificial Intelligence

AAOS Exec Chat: An Insider Look Into DePuy Synthes' Anterior Approach

Scott Zellner, senior director at DePuy Synthes, and orthopedic surgeon Joel Matta, who has been collaborating with DePuy since 2004, have long advocated for the anterior approach to total hip replacement, touting the many benefits of the minimally invasive surgery. Medtech Insight sat down with Zellner and Matta at this year's American Association of Orthopedic Surgeons' (AAOS) conference in Las Vegas to discuss the company's latest technologies designed for the anterior approach to total hip replacement, what's next, and to hear Matta's view on the widely discussed role of robotic-assisted surgeries.

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Approvals

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QUOTED. March 22, 2019. Scott Gottlieb.

US FDA recently qualified the OsiriX CDE Software Module as a Medical Device Development Tool (MDDT), making it the third MDDT qualified by the agency and the first biomarker MDDT. See what FDA Commissioner Scott Gottlieb said about it here.

Quoted FDA

No Brainer: US FDA Greenlights First Biomarker Software As Medical Device Development Tool For Brain Injury

Developers of medical devices intended to treat traumatic brain injuries may want to consider using an imaging software developed to detect contusions. The product is the third Medical Device Development Tool qualified by US FDA, which means the agency trusts it to output accurate data supporting clinical trials.

FDA Clinical Trials

Global Device Approvals, Weekly Snapshot: FDA Approves Bard’s Venovo Stent; Abbott’s MitraClip Gets Indication-Expansion; Boston Scientific’s Watchman FLX Earns CE Mark

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, FDA approved Bard’s Venovo venous stent system for symptomatic iliofemoral venous outflow obstruction, FDA added functional mitral regurgitation to the approved labeling for Abbott’s market-leading MitraClip, and Watchman FLX, Boston Scientific’s next-generation left-atrial appendage closer earned a CE Mark in Europe.

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