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 ...

The CORE-MD (Coordinating Research and Evidence for high-risk Medical Devices) consortium has published new consensus recommendations today in The Lancet Regional Health Europe, that set out ...

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 ...

The MarketWatch News Department was not involved in the creation of this content. MINNEAPOLIS, Jan. 8, 2026 /PRNewswire/ -- Flywheel, the leading medical imaging data management and analysis platform, ...

In recent years, new regulation has been top-of-mind for medtech companies wishing to continue marketing their products in Europe. In large part, this has meant navigating the requirements of the ...

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 ...

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 ...

Dublin, Dec. 18, 2025 (GLOBE NEWSWIRE) -- The "Medical Device CRO Market: Industry Trends and Global Forecasts, Till 2035 - Distribution by Target Therapeutic Area, Scale of Operation, Device Class, ...

MINNEAPOLIS, Jan. 8, 2026 /PRNewswire/ -- Flywheel, the leading medical imaging data management and analysis platform, today announced key milestones achieved in 2025. The company also recently closed ...