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Mendaera earns FDA clearance for Focalist handheld robotic system

  • Mendaera Inc. has received FDA clearance for its Focalist handheld robotic system designed to simplify and enhance precision of ultrasound-guided needle placement.
  • The company aims to make precision surgery more accessible across healthcare with a focus on providing tools to support precise and consistent needle placement across various users and clinical settings.
  • The Focalist system integrates handheld control, real-time ultrasound imaging, and advanced software, allowing for reproducible minimally invasive procedures.
  • Mendaera is commencing a limited launch of the Focalist system in select medical institutions and plans for full commercialization by 2026, starting with applications in urology.

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