Aug.12, 2026 — Mendaera Inc. has announced results from a peer-reviewed study showing that its FDA-cleared Focalist system, which combines handheld robotics, real-time imaging and intelligent guidance software, achieved technical success in 60 of 61 ultrasound-guided percutaneous procedures with zero device-related adverse events. Published in the World Journal of Urology, the study is the first prospective evaluation of a handheld robotic system for ultrasound-guided procedures across multiple specialties and supports Focalist’s potential to improve the accessibility and consistency of these procedures.
The study evaluated the Focalist system across three procedural categories — organ access, pain management and vascular access — performed by 11 physicians in the areas of urology, nephrology and anesthesiology. Physicians reported high ease-of-use following a single 45-minute training session, citing real-time trajectory planning, needle-depth tracking, an intuitive touchscreen and preserved tactile feedback during needle advancement as key highlights.
“When performing an ultrasound-guided procedure, physicians must continuously translate what they see on the screen into precise needle movement — a task that can be difficult even for experienced clinicians,” said Abhishek Singh, M.D., lead investigator and urologist at Muljibhai Patel Urological Hospital. “What stood out was how quickly physicians from different specialties began using Focalist successfully across a diverse set of procedures, aided by real-time guidance for trajectory and needle depth.”
Millions of procedures each year across many specialties involve placing a needle under ultrasound guidance. However, the technique remains technically challenging, contributing to performance variability and thereby limiting broad adoption and access to care. Mendaera’s Focalist system is designed to help more clinicians perform these procedures with greater consistency and confidence.
“Too much of procedural care today depends on specialized skills that are difficult to acquire and concentrated among too few clinicians,” said Josh DeFonzo, co-founder and CEO of Mendaera. “This study is an important milestone, demonstrating that a broader range of physicians can successfully use Focalist across a diverse range of procedures, and that we are advancing toward the goal of making high-quality minimally invasive care more accessible.”
Focalist obtained FDA 510(k) clearance in July 2025 and is in the early stages of commercialization in the U.S. The study, “Robotic guidance for ultrasound-guided percutaneous procedures: a prospective multispecialty feasibility study,” was completed in December 2025 and published in the World Journal of Urology in July 2026. It is available at link.springer.com/article/10.1007/s00345-026-06618-4.
September 15, 2026 
