The FDA’s updated list of AI/ML-enabled medical devices, which now includes 950 authorized devices, underscores the rapid growth in this field. The 37% increase fr...
The U.S. Food and Drug Administration (FDA) has recently authorised over 100 artificial intelligence (AI)-enabled medical devices across a broad range of clinical ...
The vast majority of AI/ML devices cleared between August 2022 and July 2023 went through the FDA’s 510(k) pathway. Just two devices received de novo clearance dur...
ChatEHR, artificial intelligence software developed at Stanford Medicine, is expediting chart reviews and other tasks by allowing clinicians to ask questions of medical records.
While the guidance does not provide specifics on how these risk analysis programs and documentation or monitoring could differ from traditional devices, FD...
The US Food and Drug Administration is clearing an increasing number of artificial intelligence and machine learning (AI/ML)-based medical devices through the 510(k) pathway. This ...
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enab...
These devices must undergo the full premarket approval process, and developers must submit clinical evidence that the benefits of the product outweigh the risks.53...