SAN MATEO, Calif.– Mendaera Inc. announced Thursday that the world’s first procedures using its Focalist handheld robotic system were successfully performed by urologist Karen Stern, M.D., of Mayo Clinic Arizona. The breakthrough was presented at the World Conference on Endourology and Uro-Technology (WCET), a leading global forum for advancements in minimally invasive kidney stone treatment.
Dr. Stern used Focalist to perform percutaneous nephrolithotomy (PCNL), the gold standard treatment for large kidney stones. The system enabled precise first-pass needle placement under ultrasound guidance, a critical step that allows surgeons to access the kidney while minimizing risks to surrounding organs.
“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.”
The Focalist platform integrates handheld robotics, real-time ultrasound imaging, and advanced software to provide consistent, repeatable needle placement. The debut procedures mark the beginning of the system’s limited U.S. launch in urology, with Mendaera planning to expand into 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.”
The debut highlights growing momentum in handheld surgical robotics, a field that seeks to combine precision with portability. With Focalist’s limited rollout already underway, Mendaera is positioning itself at the forefront of ultrasound-guided procedure innovation in both urology and beyond.
