The approval is expected to drive increased clinical adoption and support applications for regulatory approval in other markets.

Military veterans will have first access to Modius Spero vestibular stimulation ...

World’s First Class III Approval for a Breakthrough Medical Imaging AI: Diagens AI AutoVision® Passes Highest-Level ...

ABILITY Neurotech, a clinical-stage brain-computer interface (BCI) company developing a neural data platform to restore communication, movement and independence for individuals with severe ...

Vitacore has received a Medical Device License (MDL) from Health Canada for FormFit, a fully custom-fit medical-grade silicone CPAP mask, the first of its kind, the company says.

Arsenal Medical announced that the FDA granted investigational device exemption approval for the RADIANT pivotal trial. The ...

Artificial intelligence (AI) has practically limitless applications in health care, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...

Securing US FDA approval is a milestone for medical device companies but is only half the story with successful adoption ...

Safety issues occur more often in medical devices first approved by the European Union when compared to devices first approved in the U.S., according to a recent study published in The BMJ. In the EU, ...

Americans rely on the Food and Drug Administration to make sure that medical devices are safe. Reporting by KFF Health News has raised questions about how the FDA has dealt with some products, ...

South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...