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Medtronic received clearance from the U.S. Food and Drug Administration to use the LigaSure vessel-sealing tool with the Hugo robotic surgery system. The decision adds a technology used in more than 45 million procedures to a platform seeking to compete with Intuitive’s presence in robotic surgery.
The U.S. Food and Drug Administration explains that clear aligners are prescription devices requiring evaluation and monitoring by a dentist or orthodontist. It warns against products sold directly to consumers without professional supervision, explains their risks, and describes how to verify device clearance.