In addition to approving devices, the FDA is also actively involved in shaping the future of AI/ML in healthcare through initiatives such as the Digital Health Center of Excellence and the development of guidelines for the use of AI/ML in medical devices. These efforts aim to create a regulatory environment that supports innovation while maintaining high standards for patient safety and product efficacy. As AI/ML technologies continue to advance, the FDA’s role will be critical in ensuring that these tools are effectively integrated into the healthcare system, ultimately improving patient outcomes and advancing the field of medicine.
Find out more and get a full list of authorized AI/ML medical devices:
https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices