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Mendaera’s Focalist Robotic System Secures the US FDA 510(k) Clearance for Ultrasound-Guided Procedures

Shots:

  • Mendaera has received the US FDA’s 510(k) clearance for Focalist robotic system for ultrasound-guided procedures
  • Mendaera will begin a limited launch of its Focalist system in 2025 to initially support urology procedures like PCNL, expanding to other specialties, with full commercialization expected in 2026
  • Focalist is designed to support precise & consistent needle placement across various users & clinical settings by integrating handheld robotics, real-time ultrasound, & advanced software, with features like touchscreen targeting, robotic needle positioning, & continuous depth tracking to make medical procedures more approachable & reproducible 

Ref: Businesswire | Image: Mendaera | Press Release

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