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Unlocking the Potential of Digital Health Therapeutics: FDA-Approved Solutions for Modern Healthcare

ByJackie Orabone

Digital health therapeutics (DTx), applications increasingly powered by AI and/or machine learning, are on the rise and promise to increase access to healthcare, provide real-time monitoring of health data, improve patient engagement and adherence to treatment, and reduce healthcare costs. What Are Digital Health Therapeutics? DTx are evidence-based therapeutic interventions driven by software and technology…

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From Pilot to Policy: The FDA’s Rapid March Toward AI-Powered Drug Reviews

ByAaron Csicseri

When FDA reviewers discovered that a generative-AI pilot could slash a 3-day document review task to mere minutes—a time-savings of 99%!—it became clear that artificial intelligence is no longer an aspirational tool but a present-day catalyst for regulatory transformation. That single statistic captures why FDA is fast-tracking AI: the volume and complexity of regulatory submissions…