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Home » FDA, Intuitive spar over robotically assisted surgery devices for mastectomy
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FDA, Intuitive spar over robotically assisted surgery devices for mastectomy

Aug. 26, 2021
By Mark McCarty
The FDA has posted an advisory regarding robotically assisted surgery (RAS) for mastectomy, but the agency also pointedly noted that it is aware of studies underway for such indications without the appropriate oversight. The FDA did not name Intuitive Surgical Inc. in the notice, but the company nonetheless responded to the FDA statement by confirming the absence of any devices thus approved or cleared. The FDA had previously issued a Feb. 28, 2019, advisory stating that the safety and efficacy of RAS devices for mastectomy and the prevention or treatment of breast cancer had not been established.
BioWorld MedTech Regulatory Robotic surgery U.S. FDA

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