Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
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.
Latest From Clinical Trials
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.
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.
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.
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.
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.
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.
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.
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.
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.
You must sign in to use this functionality.
Please Sign In
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with active subscriptions will be able to access the full article. All other readers will be directed to the abstract and may purchase the article.