Mendaera Secures Breakthrough Clearance for Handheld Robotic Ultrasound System

Mendaera has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its handheld robotic system, Focalist™. The system is designed to simplify and improve the accuracy of ultrasound-guided needle placement, a complex procedure used in many medical specialties.

Needle-based image-guided procedures are a vital part of modern healthcare, used in hundreds of millions of treatments worldwide each year. 

However, these procedures rely heavily on the clinician’s skill and experience, which can vary widely and affect patient outcomes and overall system efficiency.

Mendaera’s Focalist™ system combines handheld robotics, real-time ultrasound imaging, and advanced software to assist with needle placement. 

Features include touchscreen targeting, robotic needle control, and continuous tracking of needle depth. The aim is to make procedures more consistent and easier for a wide range of healthcare professionals.

The company is starting a limited release of Focalist™ in 2025 at selected medical centres, initially focusing on urology procedures such as percutaneous nephrolithotomy (PCNL), which require accurate kidney access. 

Mendaera plans to expand the system’s use to other medical fields and expects a full commercial launch in 2026.

The technology is intended to reduce variation in care, increase safety, and make minimally invasive procedures more accessible across healthcare systems.