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AI-Enabled Medical Devices Here To Stay?

ABSTRACT: This summer, FDA published a list of AI-Enabled Medical Devices as a resource to quickly identify AI-enabled medical devices authorized for marketing in the United States. As of September 30th, FDA is also seeking public comment on measuring and evaluating the performance of AI-enabled medical devices in the real-world. Will healthcare innovators, providers and/or patients begin using these devices more than non-AI-enabled medical devices? Will public comment help shape how FDA regulates and/or approves these devices? Time will tell, but as with other areas of AI, we anticipate exciting developments are on the horizon for medical devices.

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