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The agency has only cleared robotically assisted surgical devices for certain types of cancer surgeries, such as hysterectomies, prostatectomies and colectomies, provided there is 30-day patient follow-up. Read More
The FDA cited reports of “endcap separation, O-ring seal failure and potential exposure of internal components of this device to living tissue that may lead to adverse local tissue reactions” in Magec devices. Read More
The warning letter is among a recent spate of letters by the agency aimed at stopping the marketing of unauthorized products related to the COVID-19 pandemic. Read More