medical devices

The FDA has classified a radiofrequency-based electric toothbrush as a medical device, establishing regulations to ensure the safety and effectiveness of this emerging dental technology.

The U.S. Food and Drug Administration has updated its list of authorized medical devices that incorporate augmented reality (AR) and virtual reality (VR) technologies.

As part of a broader effort to expand health outcomes across diverse populations in the U.S., the U.S. Food and Drug Administration (FDA) has published a Discussion Paper to facilitate a public discussion on how to advance health equity in connection with medical devices.

The IEEE Standards Association announced that several testing facilities operated by atsec Information Security have been officially recognized to conduct testing in accordance with the requirements of the IEEE’s Medical Device Cybersecurity Certification Program.

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has announced the expansion of its program intended to foster more efficient and expeditious development of innovative medical devices.

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and authorization of medical devices.

This article explores the evolving landscape in the medical industry, focusing on key standards such as IEC 60601-1 and new guidelines implemented to address the next generation of medical devices.

The U.S. Food and Drug Administration (FDA) has published a Final Guidance to clarify...

The Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) has released its latest reports on the agency’s activities in support of the safety and innovation of medical devices.

In this recent Application Note, SCHURTER emphasizes the importance of compliance with the medical standard DIN EN ISO 13485 to ensure the safety and reliability of medical equipment, specifically as it relates to the development and integration of HMI solutions.