The pharmaceutical and medical device industries stand at an inflection point. After decades of reliance on traditional randomized controlled trials (RCTs), computational modeling and simulation (CM&S ...

Regulatory Outlook Medical Device Clinical Trials in Japan In an effort to globally harmonize medical device clinical trials, Japan has implemented new regulations on how to develop and conduct them.

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min A medical device has received ...

Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA?

In a recent study published in Pediatric Research, researchers performed a scoping evaluation of data from clinical trials addressing high-risk pediatric medical devices used in children. Study: ...

Urologists at Vanderbilt Health are enrolling men with stress urinary incontinence (SUI) in a clinical trial named SOPHIA2 to ...

When I was working on my Masters in data science, one of the projects I did was to create an algorithm that would take an intended use statement for a medical device and predict whether FDA would ...

One of the main challenges for medical device developers is ensuring clinical trials meet the expectations of all regulatory authorities in the regions where they wish to release. This will be a ...

Q: Does the FDA regulate medical devices or only drugs? If it does regulate them, is this preventing new inventions? A: Yes, the FDA closely regulates medical devices, as it does medications. In ...

Learn about the materials and technologies powering untethered micro devices in healthcare, and discover the clinical applications in oncology and vascular disease.