Mendaera, a California-based healthcare technology company, has secured 510(k) clearance from the US Food and Drug Administration (FDA) for Focalist, a handheld robotic system.
This system is intended to enhance the accuracy and simplicity of ultrasound-guided needle placement across various medical fields, initially concentrating on urology. The company plans a limited launch in selected medical institutions this year, with full commercial availability expected in 2026.
According to Mendaera, image-guided procedures, such as the placement of needles or interventional instruments, are vital components of medical care, conducted globally in various patient encounters each year. These procedures traditionally rely heavily on an operator’s skill in coordination and spatial judgment, which can vary substantially between providers and institutions.
This variability often results in inconsistent patient experiences and inefficiencies across healthcare systems.
Focalist aims to standardise needle placement procedures through its integration of handheld robotics, real-time ultrasound imaging, and advanced software, thus facilitating more accessible medical procedures. The system incorporates features such as touchscreen targeting, robotic needle positioning, and continuous depth-tracking to ensure consistent procedural experiences.
Mendaera co-founder and CEO Josh DeFonzo said: “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.
“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.”
Operating from Silicon Valley, Mendaera focuses on creating handheld robotics that increase precision across healthcare settings. The Focalist System combines real-time imaging with intuitive robotic controls to aid clinicians in performing minimally invasive procedures consistently and effectively.
The system provides precise guidance for interventional device placement by positioning the device relative to the ultrasound transducer during diagnostic or therapeutic processes. It is suitable for both paediatric and adult patients.
