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Clinical / R & D

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Ethicon-Sponsored Trial Shows Bariatric Surgery Improves Diabetics’ Outcomes

The final five-year results from the STAMPEDE trial, said to be the first randomized controlled trial in the bariatric space, show that bariatric surgery plus intensive medical therapy is more effective than intensive medical therapy alone in combating hyperglycemia in obese patients with type 2 diabetes.

Diabetic Care Surgery Clinical Trials
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Clinical Trials

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Latest From Clinical Trials

Intensix Data Analytics Demo High Accuracy In ICU Sepsis Detection

An analytics platform developed by Israeli big data company Intensix has shown high accuracy for detecting and predicting sepsis in critical care. The positive results were presented at the Healthcare Information and Management Systems Society (HIMSS) healthcare IT conference in Orlando, Florida.

Digital Health StartUps and SMEs

Inside Look: Changes Ahead For The International Clinical Investigations Standard

Regulatory shifting sands the world over are complicating work on revising the international clinical investigations standard, ISO 14155. In this changing climate, it is important to keep requirements aligned. Danielle Giroud, founder of the World Medical Device Organization consultancy and founder/CEO of MD-CLINICALS, is convenor for the expert group (TC194 WG4) that is leading the revision. In this guest column, she explains how work is progressing.

Medical Device Regulation

Starts & Stops: Abbott's Inherited Products Add To Spike In Suspensions

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. This edition highlights an apparent trial-suspension spike in the past month, including three studies that were stopped by Abbott evaluating products it inherited from its acquisition of St Jude Medical.

Clinical Trials Research & Development
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New Technology

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Latest From Innovation

Device Debuts: Medtronic, Boston Scientific, Philips, Seventh Sense, Vortex, 410 Medical

Device Debuts is a new regular feature highlighting Medtech Insight editors’ top picks of medical devices that have been commercialized for the first time in the last month. This edition features an innovative minimally invasive surgical stapler, a pain-free blood-collection device, a novel approach for collecting, circulating tumor cells, a rapid fluid-infusion device for critically ill patients, and an EP-mapping and navigation system.

Surgery Cardiology

Device Week – February, 24, 2017

On this week's Medtech Insight podcast: the response by a US FDA advisory panel to Claret Medical's de novo submission for the first brain-filter device intended to protect patients undergoing transcatheter aortic heart-valve replacement; a reporting trip to the Israeli innovation hub; a Boston Scientific recall; and bariatric surgery data.

Device Week Metabolic

New Products Drive Medtronic’s Revenue, Profit Growth In Q3

The medtech giant announced 6% revenue growth, led by the cardiac and vascular and diabetes groups, both of which are enjoying strong market demand for new products. Medtronic expects to continue growing revenues by about five percent annually to maintain double-digit earnings growth.

Cardiology Diabetic Care
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Approvals

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Latest From Approvals

OUS Approvals Analysis: Medtronic, Abbott, Abionic Lead 2017 Upswing

The 20 non-US medical device approvals in January, including eight in in vitro diagnostics, four in orthopedics, and three in cardiovascular devices. Big medtech players Medtronic and Abbott, accompanied by much smaller Swiss IVD firm Abionic, led the charge and bagged more OUS approvals than most.

Approvals Research & Development

US Approvals Analysis: Slow 510(k) Month Includes Major Cardiac Assay Clearance

The number of 510(k) clearances in January by US FDA were lower than average, but there was at least one practice-changing advance deemed substantially equivalent last month: Roche's high-sensitivity Elecsys cardiac troponin assay. There were four original PMAs approved in January, but a lower-than-usual total of supplement approvals.

Approvals Innovation

Abbott Finally Joins MRI-Compatibility Club In US CRM Market

The firm’s Assurity MRI pacemaker and Tendril MRI pacing lead, acquired in its recent St. Jude Medical deal, gained US FDA approval after some delay. Lack of this designation has been a competitive challenge for the business in the past year.

Cardiology Approvals
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