Darshin Patel discusses the first-of-its-kind Sapien M3 TMVR system's design, development and lessons for other medical ...

A lot has changed about Cleveland Clinic Innovations, the health system’s innovation and commercialization arm, over the past quarter-century. Founded in 2000, Cleveland Clinic Innovations has gone ...

EOS GmbH, headquartered in Krailling, Germany, has announced its latest advancement in regulatory compliance support for ...

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China ...

By Sunil Inamdar, Vice President of Technical Development, Polyzen Specialized, custom-shaped low-pressure balloons are ...

The surging trend of integrating electric linear actuators into medical devices for advanced motion control demands that ...

DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to ...

Teleflex, a Pennsylvania-based medical device provider ... week with the Minnesota Department of Employment and Economic Development. The Maple Grove site, located at 6464 Sycamore Ct.

The purpose of this article is to address concerns surrounding the regulatory oversight of quality and safety standards for medical devices in the United States, including the 510(k) premarket ...

The IMDRF have recently published key concepts and principles for the development of high-quality medical devices which incorporate AI. The guidance further highlights the need for a robust framework ...

Despite the Trump administration's recent 90-day pause on reciprocal tariffs, hospitals and health systems remain concerned about the ongoing impact of tariffs on medical devices. Industry ...