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.

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 ...

ARLINGTON, Va.--(BUSINESS WIRE)--A Medical Device Innovation Consortium (MDIC) program today released a new framework that provides U.S. medical device companies a systematic approach for ...

Patients at the Ohio State Wexner Medical Center are the first in the state to participate in a clinical trial for an innovative sensor that effectively tracks patients’ fluid levels, which can assist ...

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 ...

Most people have seen the growth in artificial intelligence/ machine learning (AI/ML)-based medical devices being cleared by FDA. FDA updates that data once a year at the close of its fiscal year.

NEW YORK, June 27, 2024 /PRNewswire/ -- Lindus Health, the "anti-CRO" running radically faster, more reliable clinical trials for life science pioneers, has unveiled their all-encompassing contract ...

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 ...

From 28 April, IVDs used clinical trials will be subject to an upfront assessment by the MHRA as part of a Clinical Trial of ...

Medical device startup CoapTech‘s pediatric version of PUMA-G, its ultrasound-based device already available and FDA-approved for adults, was recently cleared for clinical testing at Children’s ...

The "Medical Device CRO Market: Industry Trends and Global Forecasts, Till 2035 - Distribution by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of ...