MobiHealth News July 8, 2025
Anthony Vecchione

The Focalist system aims to combine handheld robotics with real-time imaging to enable clinicians to place needles more precisely.

Mendaera, a robotics company, announced it has been granted FDA 510(k) clearance for Focalist, a handheld robotic system, which aims to combine handheld robotics with real-time imaging to enable clinicians to place needles with precision.

Mendaera said the system integrates robotics, ultrasound imaging and advanced software to make medical procedures more accessible.

Among Focalist’s features are touchscreen targeting, robotic needle positioning and continuous needle depth tracking, enabling a reproducible procedure experience.

While needle placement is used for a variety of procedures and in a broad range of clinical settings, the initial focus of the system will be in urology....

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Topics: FDA, Govt Agencies, Medical Devices, Robotics/RPA, Technology
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