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Clinical Trials

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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 Medical Device
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Latest From Clinical Trials

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

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

New Registry Could Lead To Expanded Stroke Device Indications

FDA recently brought together stakeholders to talk about developing a coordinated registry network for stroke devices. Both clinicians and companies see promise in the effort, but more questions need to be answered, experts tell Medtech Insight.

Regulation Neurology

Starts & Stops: S-ICD And Respiratory App Studies Among Year-End Large-Scale Trial Launches

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions over the past month. This edition notes the particularly high number of large-scale trials launched toward the end of 2016.

Clinical Trials Research & Development

Stroke-Device Registry Will Be Focus Of February FDA Meeting

A Feb. 2 workshop, which will focus on the prospects of a registry for devices used for acute ischemic stroke intervention, fits into US FDA's expanding focus on leveraging registries to support regulatory decision-making.

Policy & Regulation Neurology

Abbott Highlights Predictive Potential Of Troponin Testing

Findings from the WOSCOPS trial indicate that high-sensitivity cardiac troponin testing may be able to identify patients at greatest risk of future coronary events and to assess their response to preventative interventions, including statins.

In Vitro Diagnostics Cardiology

Dexcom Glucose Test System Approved For 2-Year-Olds

US FDA has heeded the advice of a July advisory committee that overwhelmingly supported expanding Dexcom's G5 Continuous Glucose Monitoring System for patients 2 and older. The company says the expanded indication will have a huge transformational effect on how patients with diabetes are treated and how such products are reimbursed.

Business Strategies Clinical Trials

Genomic Health Gets KO'd By Next-Gen Long-Term Breast Cancer Assays

The new-generation of tests from Myriad and NanoString have outperformed Genomic Health's Oncotype Dx in predicting which breast cancer patients are at low-risk for a recurrence in five to ten years, and therefore do not need to be on extended endocrine therapy.

Innovation Clinical Trials
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