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FDA-approved surgical robots trend toward autonomy, study finds

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A systematic review in npj Digital Medicine categorizes FDA-approved surgical robots by their levels of autonomy, highlighting a need for standardized definitions and greater regulatory clarity as these systems evolve towards higher autonomy.

By Dr. Liji Thomas, MDApr 29 2024Reviewed by Benedette Cuffari, M.Sc. A recent review published in the journal npj Digital Medicine examines the current categories of surgical robots that have been approved by the United States Food and Drug Administration based on Levels of Autonomy in Surgical Robotics .

To date, there remains no defined platform to classify these different systems. Currently, the only way to classify these instruments is by using the system applied for industrial robots and self-driving vehicles. The review included all Class II surgical robots approved by the FDA since 2015. Each robot was examined using LASR criteria for autonomy classification.

The first 15 robotic systems received clearance before 2015 and were subsequently approved for additional capabilities. Thereafter, 24 robots were introduced from Level 1 to Level 3. Throughout this period, task automation increased, with mostly Level 2 robots introduced since 2017.

 

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