Prospective multispecialty study reported no device-related adverse events across 61 procedures, with technical success achieved by first-time Focalist system users after a single 45-minute training session

SAN MATEO, Calif., Aug. 12, 2026 /PRNewswire/ — Mendaera Inc., a healthcare technology company elevating procedural medicine, today 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. The study builds upon earlier procedural evidence previously presented during WCET 2025, ASRA 2026, and AUA 2026. The open-access study is available at https://link.springer.com/article/10.1007/s00345-026-06618-4.

About Mendaera

Mendaera is building a new category of handheld robotics designed to make precision more accessible across healthcare. With its Focalist™ system, combining real-time imaging and guidance software with intuitive handheld robotic control, Mendaera supports clinicians in delivering consistent, high-quality care across a broad range of minimally invasive procedures and settings.

Based in Silicon Valley, California, the company is backed by leading investors and a leadership team with a track record of successful outcomes, including Auris Health.

Mendaera’s Focalist™ system has FDA clearance in the U.S. to provide guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and resulting image during diagnostic or therapeutic procedures. The system is intended for use with pediatric and adult patients. The system is used with select compatible FDA-cleared ultrasound probes.

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SOURCE Mendaera, Inc.