San Mateo, California, August 12, 2026
Mendaera Inc. announced results from a new peer-reviewed prospective multispecialty study showing that its FDA-cleared Focalist™ system achieved 98% technical success across ultrasound-guided percutaneous procedures in urology, nephrology, and anesthesiology. Technical success was achieved in 60 of 61 procedures, with no device-related adverse events reported. The findings, published in the World Journal of Urology, provide clinical evidence supporting the use of handheld robotics, real-time imaging, and intelligent guidance software to assist physicians performing minimally invasive procedures.
Focalist Demonstrates High Technical Success
The prospective study evaluated Focalist across 61 ultrasound-guided procedures spanning three procedural categories: organ access, pain management, and vascular access. A total of 11 physicians from urology, nephrology, and anesthesiology participated in the evaluation. According to the study findings, the system achieved technical success in 60 procedures, representing a 98% technical success rate, while no adverse events related to the device were reported. The study is described as the first prospective evaluation of a handheld robotic system for ultrasound-guided procedures across multiple medical specialties. Focalist combines handheld robotic control, real-time imaging, and intelligent guidance software to assist clinicians with precise instrument placement. The system provides features including real-time trajectory planning, needle-depth tracking, and an intuitive touchscreen interface while preserving tactile feedback during needle advancement. These capabilities are designed to help clinicians translate ultrasound images into controlled and precise needle movements during procedures.
Multispecialty Physicians Achieve Success After Training
A key finding from the evaluation was the reported ease of use among physicians following a single 45-minute training session. First-time Focalist users successfully performed procedures across different specialties and procedural categories, highlighting the potential for the technology to support clinicians who may have varying levels of experience with ultrasound-guided interventions. Ultrasound-guided needle procedures are performed across numerous medical specialties, but the technique can require substantial technical skill, spatial coordination, and procedural experience. Differences in clinician experience can contribute to variability in procedural performance and may limit access to certain minimally invasive interventions. Mendaera designed Focalist to provide real-time guidance that can help clinicians control instrument trajectory and depth while maintaining the tactile sensation associated with conventional needle advancement. The study’s lead investigator, Abhishek Singh, M.D., highlighted the ability of physicians from different specialties to begin using the system successfully after limited training. The findings suggest that robotic guidance may help make technically demanding ultrasound-guided procedures more consistent and accessible across a broader range of clinical environments.
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FDA-Cleared Technology Expands Procedural Robotics
The latest study adds to the clinical evidence supporting Focalist, which received FDA 510(k) clearance in July 2025 and is now in the early stages of commercialization in the United States. The system is cleared to provide guidance for precise placement of compatible interventional instruments by positioning the device relative to an ultrasound transducer and the resulting ultrasound image during diagnostic or therapeutic procedures. It is intended for both adult and pediatric patients when used with compatible FDA-cleared ultrasound probes. The prospective study was completed in December 2025 and published in the World Journal of Urology in July 2026. It builds on earlier procedural evidence presented at medical meetings, including WCET 2025, ASRA 2026, and AUA 2026. The latest peer-reviewed findings provide additional clinical support for Mendaera’s approach to combining robotics with ultrasound guidance. For the broader MedTech and surgical robotics sector, the results highlight efforts to make precision-based procedures less dependent on highly specialized technical skills. While the study provides encouraging evidence regarding technical success, usability, and device safety, broader clinical adoption and the technology’s impact on patient outcomes will require continued evaluation. Mendaera is positioning Focalist as a platform designed to improve consistency and accessibility in minimally invasive procedural care across multiple specialties.
Source: Mendaera press release
