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Mendaera Receives FDA 510(k) Clearance for Handheld Robotic System
Pioneering a new category of robotics in healthcare, Mendaera’s Focalist™ System, cleared for precise instrument placement during ultrasound-guided procedures, is poised to transform one of medicine’s most common and critical techniques
SAN MATEO, CA – July 08, 2025 – 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.
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 with intuitive, handheld robotic control, Mendaera aims to support clinicians in delivering consistent, high-quality care across a broad range of minimally invasive procedures and settings. Based in Silicon Valley, CA, the company is backed by leading investors and a leadership team successful in taking early-stage medical technology companies through to successful exits, including Auris Health. Mendaera's Focalist™ System has been cleared for use in the USA to provide guidance for precise instrument placement of common interventional devices by positioning the device relative to the ultrasound transducer and the resulting image during a diagnostic or therapeutic procedure. This guidance system is intended for use with pediatric and adult patients. Mendaera.com
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