Mendaera Wins FDA Clearance for Handheld Robotic Needle System

Mendaera Inc. 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 multiple medical specialties. The system integrates handheld robotics, real-time ultrasound imaging, and advanced software featuring touchscreen targeting, robotic needle positioning, and continuous depth tracking to enhance reproducibility and safety in procedures such as biopsies, organ access, and vascular access. The company plans a limited launch in 2025 focused initially on urology procedures like percutaneous nephrolithotomy, with full commercialization expected in 2026. CEO Josh DeFonzo emphasized that the technology aims to increase provider confidence and capabilities in these challenging but foundational techniques, potentially democratizing access to minimally invasive procedures. Experts like Dr. Gerhard J. Fuchs highlight that combining ultrasound with robotics can reduce radiation exposure and improve visualization, thereby raising the standard of care. Mendaera’s innovation addresses the variability in operator skill, aiming to deliver more consistent and efficient patient outcomes across healthcare systems.