Anna Bager, President and CEO of OAAA
Pharma advertising is entering a period of accelerated change. As the Food and Drug Administration increases oversight of direct‑to‑consumer promotions, marketers are rethinking how they reach patients and…
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The goal is to make artificial intelligence available to the federal workforce and to integrate it across internal operations, research and public health.The Department of Health and Human Services has released an AI strategy…
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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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