In context
In mid-2025, medical robotics was expanding beyond surgical suites into everyday interventional procedures. Ultrasound-guided needle placement, a common but skill-dependent task, remained a target for automation to improve consistency and access.
What was reported
Mendaera received FDA 510(k) clearance for Focalist, a handheld robotic system designed for ultrasound-guided needle placement. The system integrates handheld robotics, real-time ultrasound imaging, and software with touchscreen targeting, robotic needle positioning, and continuous depth tracking to enable reproducible procedures.
The company began a limited launch in 2025 with select institutions, focusing initially on urology procedures such as percutaneous nephrolithotomy (PCNL), where precise kidney access is critical. Full commercialization is anticipated in 2026.
Mendaera's CEO Josh DeFonzo emphasized that precise needle placement underpins many care journeys, and robotics can increase provider capabilities in everyday procedures. Dr. Gerhard J. Fuchs of USC noted that pairing ultrasound with robotics can lower the barrier to precise access and instrument placement.
Why it mattered
This clearance signaled a shift toward democratizing interventional skills, potentially reducing variability in outcomes and expanding access to minimally invasive procedures across specialties—an important step for healthcare automation beyond the operating room.
“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.”
Source: Robotics & Automation News (roboticsandautomationnews.com) · Published 2025-07-08 · “Mendaera receives FDA clearance for handheld robotic system for ultrasound-guided needle placement”