Mendaera's Focalist Handheld Robotic System Receives FDA Clearance for Ultrasound-Guided Procedures
Key Insights
Mendaera (search) received FDA 510(k) clearance for its Focalist (search) handheld robotic system designed to enhance precision in ultrasound-guided needle placement procedures.
The system integrates handheld robotics, real-time ultrasound imaging, and advanced software with touchscreen targeting and continuous needle depth tracking capabilities.
Initial limited launch begins in 2025 focusing on urology procedures like percutaneous nephrolithotomy (search), with full commercialization expected in 2026.
Mendaera (search), Inc., a healthcare technology company focused on developing universal medical robotics, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its handheld robotic system, Focalist (search). The novel system is designed to simplify and enhance the precision of ultrasound-guided needle placement, addressing a technically demanding procedure performed across many specialties and care settings.
Addressing a Critical Healthcare Challenge
Image-guided procedures involving the placement of needles or other common interventional instruments are a cornerstone of medical care, used in hundreds of millions of patient encounters globally each year. Despite being commonplace, successful procedures are highly dependent on the operator's coordination, spatial judgment and experience—skills that are hard to acquire and vary significantly across providers and institutions, leading to inconsistent patient experiences and system-wide inefficiencies.
"Precise placement of needles to perform a wide range of procedures—organ access, biopsies, vascular access or therapy delivery, as examples—is a very challenging, but foundational technique that underpins most patient care journeys," said Josh DeFonzo, co-founder and CEO of Mendaera (search). "Our mission is to ensure that these procedures are delivered safely and efficiently across the healthcare system by enabling more providers with the confidence needed to perform these techniques."
Technology Integration and Features
Focalist (search) is designed to support precise and consistent needle placement across a breadth of users and clinical settings. The system integrates handheld robotics, real-time ultrasound imaging, and advanced software that makes medical procedures more approachable. Key features include touchscreen targeting, robotic needle positioning, and continuous needle depth-tracking, enabling a reproducible procedure experience.
The technology represents what experts describe as a meaningful evolution in minimally invasive procedures. 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 (search)'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.
Commercial Launch Strategy
Mendaera (search) will initiate a limited launch of its Focalist (search) System in leading institutions during 2025, supporting procedures in urology such as percutaneous nephrolithotomy (search) (PCNL), where precise access to the kidney is required, and expanding to other specialties thereafter. The company anticipates full commercialization of the Focalist System in 2026.
Broader Industry Context
The clearance of Mendaera (search)'s Focalist (search) 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 healthcare 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.
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.