After winning FDA authorization for CMR's Versius, Slack offered advice for navigating the de novo pathway and new ...

Medtronic — the world's largest medical device company — is preparing for potential new import taxes and other policy changes ...

The former CTO of IBM explains IEEE 2933, a new healthcare cybersecurity standard from the IEEE Standards Association.

The CDC wants Alveo to make rapid, portable A(H5) diagnostic tests "to support response efforts in the event of an outbreak." ...

Researchers at UBC say they developed a new coating that could reduce risks associated with some medical devices.

Polymer Medical has achieved ISO 13485:2016 certification, the standard for QMS in the medical device industry.

Nearly 300 people blamed cancers on ethylene oxide (EtO) emissions from a device sterilization facility once operated by a ...

The MDO Medical Device Handbook is devoted to device design, development and manufacturing tips and intelligence from experts you can trust.

Westpak said its new laboratory in Union City, California, expands the medtech testing provider's capacity and capabilities ...

Balancing catheter flexibility and stiffness has long vexed device designers and engineers trying to access the human anatomy ...

Resonetics is "making major changes" to decrease medical nitinol lead times, Nitinol Business Development VP Eric Veit tells ...