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

“The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in GB, ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

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

Dedicated to shedding light on the intricate layers of European regulation, integrated cybersecurity features, and forecasted uncertainties around AI, the 2nd Medical Device Software Development ...

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

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

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

The FDA this week issued a draft guidance with recommendations for submitting medical devices that include AI_enabled ...

Karl Storz announced today that it acquired the medical business of T1V, a visual collaboration software company.