Mendaera Achieves 1st Procedures with Focalist Handheld Robotic System

Mendaera announced the world’s first procedures performed with its Focalist handheld robotic system.

Urologist Karen Stern, M.D., (Mayo Clinic Arizona) successfully used Focalist to achieve precise kidney access during percutaneous nephrolithotomy (PCNL), the gold standard treatment for large kidney stones.

PCNL begins by placing a needle into the kidney under imaging guidance to create a pathway for stone removal. This first step requires precision to avoid nearby organs and allow optimal and effective stone clearance. Using Focalist, Dr. Stern and her team achieved rapid, efficient, and precise first-pass needle placement into the ideal kidney location.

Dr. Stern said she was thrilled to be the first in the world to use the Focalist system. It was cleared by the U.S. Food and Drug Administration (FDA) in July of this year.

“I found it intuitive to learn and easy to integrate into my workflow,” she told the press. “Focalist enhances needle control and simplifies precise placement under ultrasound, particularly for operators with less experience. It has the potential to build confidence in ultrasound-guided access and lower the barrier to proficiency across providers with varying levels of experience.”

Focalist merges handheld robotics, real-time ultrasound, and advanced software to provide precise, repeatable instrument placement. Its first procedures mark the start of Focalist’s limited U.S. launch in urology, with expansion to other specialties planned in 2026.

“These first procedures underscore Focalist’s ability to deliver highly precise, consistent needle placement—a foundational requirement across all of medicine,” said Josh DeFonzo, co-founder and CEO of Mendaera. “We’re proud to partner with Dr. Stern as she pioneers ultrasound-guided access in urology. We believe Focalist will empower more healthcare providers to perform procedures with confidence. This milestone brings us closer to our mission of broadening access to minimally invasive procedures and elevating standards across the healthcare system.”