StoryRegulatory

FDA clears HYDROS, PROCEPT's next-generation Aquablation robot with AI treatment planning

PROCEPT BioRoboticsHYDROS Robotic System (Aquablation)

The FDA cleared HYDROS, the second-generation robot for Aquablation. It adds FirstAssist AI, which helps surgeons read ultrasound landmarks using data from more than 50,000 procedures, plus integrated imaging and a simpler workflow. More than 400 earlier systems were installed in the US at the time.

  • 510(k) clearance; full US release planned within the quarter.
  • FirstAssist AI planning built on 50,000+ real-world procedures.
  • Integrated ultrasound and a new single-use digital scope.
  • 400+ robotic Aquablation systems installed in the US then.
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