Mendaera announces first procedures with Focalist handheld robotic system

Healthcare technology company Mendaera, which is developing next-generation robotics technology to simplify ultrasound-guided needle procedures, announced the world’s first medical 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), a treatment for large kidney stones.

Dr. Stern presented the procedures at the World Conference on Endourology and Uro-Technology (WCET), a global meeting for surgeons advancing minimally invasive kidney stone treatment.

Kidney procedure requires precise guidance

PCNL begins with the placement of a needle into the kidney under imaging guidance, creating a pathway for stone removal. This critical first step requires extreme precision to avoid surrounding organs and to enable optimal and effective stone clearance.

Using Focalist, Mendaera said Dr. Stern and her team achieved rapid, efficient and precise first-pass needle placement into the ideal kidney location.

“I was thrilled to be the first in the world to use the Focalist System,” Dr. Stern said. “I found it intuitive to learn and easy to integrate into my workflow. 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.”

Mendaera said the Focalist system combines handheld robotics, real-time ultrasound and advanced software to enable precise, repeatable instrument placement.

These procedures mark the beginning of the limited U.S. launch of Focalist in urology, with expansion to additional specialties planned in 2026, according to Mendaera.

“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.”