Mendaera today announced the world’s first procedures performed with its Focalist handheld robotic surgery system.
The procedures — the world’s first using Focalist — were performed by urologist Dr. Karen Stern of Mayo Clinic Arizona. Stern used Focalist to achieve precise kidney access during percutaneous nephrolithotomy (PCNL), the gold standard treatment for large kidney stones. She presented the milestone cases at the World Conference on Endourology and Uro-Technology (WCET).
PCNL starts with the placement of a needle into the kidney under imaging guidance, creating a pathway for stone removal. This step requires precision to avoid the surrounding organs and enable effective stone clearance. Using focalist, 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,” 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.”
More about the Mendaera Focalist system
Focalist combines handheld robotics, real-time ultrasound and advanced software to enable precise, repeatable instrument placement.
Mendaera received FDA clearance for Focalist in July, and the company has an ongoing partnership with Cook Medical over needle-based robotic interventions. It says the first-time procedures mark the beginning of its limited U.S. rollout for Focalist in urology. The company expects an expansion to additional specialties 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.”
