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FDA seeks input on benefits-risks of autonomous robotic medical devices

A photo of a doctor in scrubs performing surgery remotely while staring at a monitor showing an operating room..
Photo: TPG/Getty Images

Agency says no remotely teleoperated or fully autonomous robotic devices have received US authorization to be marketed.

To help evaluate the benefits, risks, and regulatory considerations for robotic medical devices with autonomous or remote teleoperation capabilities, the US Food and Drug Administration (FDA) has issued and is inviting public input on a discussion paper.

According to the FDA, while rapid advances in AI, machine learning, and connectivity

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