Mendaera earns FDA clearance for Focalist handheld robotic system - The Robot Report

Mendaera Inc., based in San Mateo, California, has received FDA 510(k) clearance for its Focalist handheld robotic system, designed to improve the precision and ease of ultrasound-guided needle placement across various medical specialties. This technology aims to address the challenges of needle-based interventions—such as organ access, biopsies, and vascular access—that require high operator skill and experience, which can vary widely and affect patient outcomes. Focalist integrates handheld control, real-time ultrasound imaging, touchscreen targeting, robotic needle positioning, and continuous needle depth tracking to enable consistent, minimally invasive procedures. The company, backed by prominent investors and having raised $73 million in Series B funding led by Threshold Ventures, is positioning Focalist as a new category of handheld robotics to make precision surgery more accessible and efficient. Initial commercialization efforts will focus on urology procedures like percutaneous nephrolithotomy (PCNL), with plans to expand into other specialties. Experts highlight the system’s potential to enhance safety,