US healthcare technology startup Mendaera Inc. said it has completed the world’s first medical procedures using its Focalist handheld robotic system, developed to simplify ultrasound-guided needle placement.
The procedures were performed by urologist Karen Stern at Mayo Clinic Arizona during percutaneous nephrolithotomy (PCNL), the gold standard treatment for large kidney stones. Stern presented the milestone at the World Conference on Endourology and Uro-Technology, a leading global forum for advances in minimally invasive kidney stone treatment.
PCNL begins with placing a needle into the kidney under imaging guidance, a critical first step that demands accuracy to avoid surrounding organs and enable optimal stone removal. Using Focalist, Stern and her team achieved rapid, 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. “It was intuitive to learn and simple to integrate into my workflow. Focalist enhances control and simplifies ultrasound-guided placement, particularly for operators with less experience.”
The Focalist system combines handheld robotics, real-time ultrasound, and advanced software to support accurate, repeatable procedures. Mendaera said these initial cases mark the beginning of a limited U.S. launch in urology, with expansion into other specialties planned for 2026.
“These first procedures underscore Focalist’s ability to deliver highly precise, consistent needle placement — a foundational requirement across medicine,” said Josh DeFonzo, Mendaera’s co-founder and CEO of the 2020-founded healthcare company. “This milestone brings us closer to broadening access to minimally invasive procedures and elevating standards across healthcare.”
