FDA OKs Mendaera’s Focalist Handheld Robotic System

Mendaera, a company developing robotics that can be deployed universally in medicine, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Focalist handheld robotic system.

The system was designed to simplify and enhance the precision of ultrasound-guided needle placement. The company began a limited launch with select medical institutions, with its first focus on urology.

Focalist integrates handheld robotics, real-time ultrasound imaging, and advanced software to make procedures more approachable, the company said. It also features touchscreen targeting, robotic needle positioning, and continuous needle depth tracking to enable a reproducible experience.

In its limited launch, Focalist will support urological procedures like percutaneous nephrolithotomy (PCNL), where precise access to the kidney is required, and expanding to other specialties thereafter. Full launch is expected in 2026.

“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.”

Earlier this year, the company appointed Eric Davidson as its first chief commercial officer (CCO). He will lead the company’s commercialization efforts as it markets its robotic technologies.