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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This project represents the first systematic assessment of the US Food and Drug Administration’s postmarket surveillance of legally marketed artificial intelligence and machine learning based medical devices. We focus on the Manufacturer and User…
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We live in interesting regulatory times. In January, a bill was introduced to the US Congress proposing that AI “can qualify as a practitioner eligible to prescribe drugs” if overseen by the States and…
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Marcus Capone, Co-Founder & CEO, TARA Mind
Mental health care is experiencing a historic transformation. The FDA’s recent expansion of Spravato (esketamine) for standalone use signals a new era in treatment, and breakthrough therapies like…
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In this interview, Dr. Samir Shah, Chief Medical Officer at Qure.ai, shares why achieving FDA approval is crucial for their AI solutions and for fostering trust in the technology. Dr. Shah discusses how their…
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News
FDA issues draft guidance for supporting development and marketing of AI-enabled devices throughout the Total Product Life Cycle. It also publishes draft guidance for the use of AI to support development of drugs and…
In a letter to Dr. Michelle Tarver, newly appointed director of the Center for Devices and Radiological Health, a division of the Food and Drug Administration, seven members of Congress have asked the agency…
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Introduction
Artificial Intelligence (AI) is rapidly transforming healthcare, offering revolutionary tools for diagnosis, treatment, and patient care. However, the complexity and potential risks associated with AI necessitate robust regulation to ensure its safe and effective…
