Safety and regulatory aspects of the FLEX robot

A recent article in IEEE Spectrum about the FLEX robot featured some interesting thoughts about the current US regulatory environment of surgical robots:
  • "the biggest hassle was ensuring that the robot was dumb enough to meet the U.S. Food and Drug Administration’s (FDA’s) requirements.   
  • “When we approached the FDA, almost the first question out of their mouth was about the autonomous nature of the robot. They raised it as a serious red flag,” says Medrobotics CEO Samuel Straface. “We had to show that the surgeon has complete and absolute control at all times. If it was any other way, we’d still be a science project,” he says.
  • the FDA has barred anything resembling an autonomous robotic assistant from the operation room.
  • If a smarter surgical tool can make a procedure less risky, the FDA may give it approval."
Just wait and see until our IEC/TR60601-4-1: Medical electrical equipment – Part 4-1: Guidance and interpretation– Medical electrical equipment and medical electrical systems employing adegree of autonomy comes out.
Source: IEEE Spectrum


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