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Robotic surgery complaints become FDA complaints

Thu, 01/02/2014 - 5:05pm
Mass Device

The FDA's postmarket surveillance programs come under harsh scrutiny amid concerns about Intuitive Surgical's da Vinci robot-assisted surgical machine.

Robotic surgery complaints become FDA complaints

As patient complaints mount in lawsuits against Intuitive Surgical (NSDQ:ISRG) and its da Vinci robot-assisted surgical platform, physicians and researchers are shifting some of the blame to the FDA's postmarket surveillance systems as an inadequate tool for protecting the public.

Sources cited in a recent Bloomberg report varied in calling FDA's medtech surveillance "a disaster" and generally riddled with conflicts of interest, some framing the embattled Intuitive Surgical as a mere "poster child" for larger problems at the federal watchdog agency.

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