Mendaera receives FDA Clearance for handheld robotic system for ultrasound-guided procedures

Handheld robotic system for ultrasound-guided procedures receives FDA Clearance: ©Mandaera

Mendaera Inc. has received U.S. Food and Drug Administration 510(k) clearance for its handheld robotic system, Focalist, the company announced. The technology is designed to improve the precision and ease of ultrasound-guided needle placement, a technically challenging but essential procedure across multiple medical specialties.

The Focalist System integrates handheld robotics, real-time ultrasound, and advanced software to help clinicians consistently and accurately place needles during procedures like organ access, biopsies, vascular access, and therapy delivery. The system uses touchscreen targeting, robotic needle positioning, and continuous needle depth tracking to enhance reproducibility and ease of use.

“Precise placement of needles to perform a wide range of procedures—organ access, biopsies, vascular access, or therapy deliveries, as examples—is a very challenging, but foundational technique that underpins most patient care journeys,” said Josh DeFonzo, co-founder and CEO of Mendaera. “Our mission is to ensure that these procedures are delivered safely and efficiently... by enabling more providers with the confidence needed to perform these techniques.”

The company will begin a limited launch of the system in 2025 with select medical institutions, initially focusing on urology procedures such as percutaneous nephrolithotomy. Broader commercial rollout is expected in 2026.

Gerhard J. Fuchs, professor of clinical urology at the University of Southern California, noted that the combination of ultrasound imaging and robotics may improve access to minimally invasive procedures. “Mendaera’s platform represents a meaningful evolution—one with the potential to broaden access to minimally invasive procedures and elevate the standard of care,” Fuchs said.

Robotics and imaging: A new era in minimally invasive procedures

The clearance of Mendaera’s Focalist system highlights the broader trend of integrating robotics and real-time imaging to democratize precision medicine. As pressure grows to improve patient outcomes while reducing procedure times and complication rates, the health care sector has increasingly turned to robotic assistance to enhance standard techniques.

Traditionally, image-guided interventions have demanded a high degree of skill, often resulting in variable outcomes depending on a provider’s experience. Robotic systems are being developed to bridge this gap by improving spatial accuracy and repeatability—particularly in ultrasound- and fluoroscopy-guided interventions. Handheld and semi-autonomous devices are becoming more common in areas such as vascular access, nerve blocks, tumor ablations, and biopsies, with the goal of reducing reliance on operator expertise.

Recent advances include compact robotic arms, AI-enhanced targeting software, and sensor-enabled tools that provide real-time feedback on tissue resistance or positioning. These technologies are designed not just for the operating room, but for outpatient settings and even rural or underserved locations where access to highly specialized expertise is limited.

Moreover, the convergence of robotics with imaging modalities such as 3D ultrasound and augmented reality is enabling clinicians to "see" and manipulate anatomy with unprecedented clarity. Such capabilities are fostering a new generation of minimally invasive, high-precision treatments that are safer for patients and more scalable across healthcare systems.

As these technologies continue to evolve, their integration into everyday care—not just high-end surgical procedures—may help close the gap in procedural quality and expand access to safe, effective treatment options across a range of clinical settings.