Zynex, based in Englewood, shipped patients excessive volumes of devices each month, using these fraudulent billings to ...

For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...

Wireless features are becoming standard in modern medical devices, but they add complexity to product safety compliance across regions and regulatory frameworks. This webinar explores how to identify ...

Language Scientific has provided a practical overview of IFU translation requirements for medical device documentation, ...

In pain relief and physical rehabilitation, TENS-based therapies are widely used to support non-pharmacological treatment strategies. Reusable electrode pads enable patients to conduct multiple ...

Covestro displayed new medical devices using advanced polycarbonate materials for home healthcare and military applications.

This increase in activity comes as the UK looks to enhance its standing in the medtech sector as global competition mounts.

Masimo stock jumped on a report of a potential acquisition. The company is perhaps best known for its yearslong patent dispute with Apple.

After January's winter storm, Nashville Electric Service has been under fire for leaving customers with medical devices stranded with no power, but the utility announced that’s all about to change.