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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
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FDA issues draft guidance for supporting development and marketing of AI-enabled devices throughout the Total Product Life Cycle. It also publishes draft guidance for the use of AI to support development of drugs and…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…
Continue Reading
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…
