The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...

Korea designates 29 innovative medical devices, prioritizes GMP review for 2025 Korea identifies 29 cutting-edge health ...

Neuralink continues its push in the brain-computer interface space with a third implant, while competitors and researchers ...

Elon Musk didn’t provide any details about the latest patient to get an implant from his brain-computer interface company, ...

Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed ...

The Food and Drug Administration announced that Philips recalled the software following 109 reported injuries and two ...

Fischer Medical Ventures announced that its wholly owned subsidiary, Time Medical International Ventures (India) has become the first indigenous MRI manufacturer in India to receive the official ...

The FDA announced today that a Philips recall involving remote cardiac monitoring software is Class I, its most serious ...

The sensitive data of millions of American adults and children have been compromised after hackers targeted California-based ...