There are many myths around premarket approval, such as the idea that PMAs always require clinical data or that it isn’t possible to point to a predicate or substantial equivalence in the filing, Drues said during his latest podcast with Medical Design & Outsourcing.
FDA itself has been offering more guidance around the PMA process and proposing ways to make PMAs less scary for medtech innovators.
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Intuitive Surgical enjoyed a nearly two-decade monopoly in the robot-assisted surgery space. At DeviceTalks West, we'll delve into that history as longtime CEO Gary Guthart tells us how he got his start in medtech, how Intuitive came to enjoy such a commanding lead and what the future holds for medical robotics.
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