Insider Brief
- Mendaera, Inc. has received FDA 510(k) clearance for Focalist™, a handheld robotic system designed to assist with ultrasound-guided needle placement.
- The system integrates robotics, real-time imaging, and software to improve precision and consistency in procedures such as organ access, biopsies, and therapy delivery.
- The company is beginning a limited launch with medical institutions, starting with urology, targeting greater provider confidence and reduced variability across clinical settings.
PRESS RELEASE – Mendaera, Inc., a healthcare technology company focused on developing robotics that can be deployed universally in medicine, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its handheld robotic system, Focalist™. The novel system is designed to simplify and enhance the precision of ultrasound-guided needle placement — a technically demanding procedure performed across many specialties and care settings. The company is commencing a limited launch with select medical institutions with an initial focus in urology.
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. “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. Robotics have been shown to increase provider capabilities in complex procedures, and we intend to demonstrate that the same can be true in everyday care.”
Focalist™ 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. Focalist™ features touchscreen targeting, robotic needle positioning, and continuous needle depth-tracking, to enable a reproducible procedure experience.
“Simplifying ultrasound-guided percutaneous access is one of the most impactful ways to improve efficiency, safety, and independence in urology and beyond,” said Dr. Gerhard J. Fuchs, Professor of Clinical Urology at the University of Southern California. “Ultrasound guidance offers the benefits of reduced radiation and better visualization of key anatomy, and when paired with robotics, can lower the barrier to precise access and instrument placement. Mendaera’s platform represents a meaningful evolution — one with the potential to broaden access to minimally invasive procedures and elevate the standard of care.”
Mendaera will initiate a limited launch of its Focalist™ System in leading institutions during 2025, supporting procedures in urology such as percutaneous nephrolithotomy (PCNL), where precise access to the kidney is required, and expanding to other specialties thereafter. The company anticipates full commercialization of its Focalist™ System in 2026.
