(RTTNews) - Medtronic plc (MDT) said it has received CE or Conformité Européenne Mark for the Hugo robotic-assisted surgery system, authorizing the sale of the system in Europe.
CE Mark approval is for urologic and gynecologic procedures, which make up about half of all robotic procedures performed today.
The Hugo RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability.
In the EU, the Hugo RAS system is CE marked. In the U.S., the Hugo RAS system is an investigational device not for sale. Touch Surgery Enterprise is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition.
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