What You Should Know:
– The U.S. Food and Drug Administration (FDA) has recently issued several key clearances, marking significant advancements across diagnostics, surgery, and remote patient monitoring.
– These FDA clearances reflect a deepening integration…
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These technologies introduce new considerations regarding safety and effectiveness across the total product life cycle.The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating…
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FDA Advisory Committee Meeting Overview
The Food and Drug Administration (FDA) is taking a significant step forward in evaluating artificial intelligence applications in healthcare by convening its Digital Health Advisory Committee on November 6, 2024….
What You Should Know:
– Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ArteraAI…
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What You Should Know:
– The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use.
– The…
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What You Should Know:
– PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its digital…
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Image Credit: bipartisanpolicy
What You Should Know:
– A new report from the Bipartisan Policy Center (BPC) examines the complex and often fragmented regulatory landscape for health AI tools that fall outside the jurisdiction of the…
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Regulatory agencies, such as the European Commission and the U.S. Food and Drug Administration, are now permitting electronic instructions for use (eIFUs) to be distributed alongside paper instructions for use (IFUs) for medical devices….
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Revolutionary AI Platform Announcement
The U.S. Food and Drug Administration has officially launched Elsa, a groundbreaking generative FDA AI technology designed to revolutionize how agency employees perform their daily tasks. This innovative platform represents a…
The U.S. Food and Drug Administration on Monday announced the launch of a new generative AI technology that agency leaders said will help its employees do their jobs more efficiently.WHY IT MATTERSThe tool, called…
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