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Intuitive Surgical files reply in support of judgment in US antitrust case over surgical robots

( May 25, 2023, 20:40 GMT | Official Statement) -- MLex Summary: Intuitive Surgical filed a reply in support of its motion for summary judgment against antitrust claims over its use limits on its precision surgical instruments, saying the US Food and Drug Administration requires it to employ appropriate measures to provide “reasonable assurance of safety and effectiveness.” “It is also undisputed that ‘remanufacturing’ a Class II medical device is unlawful absent FDA clearance, and that FDA has repeatedly and consistently stated that modification of an EndoWrist to bypass its use counter to add uses constitutes ‘remanufacturing,’” it said.See document below. ...

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