First PCNL procedures with Focalist handheld robotic system debut at WCET

The first procedures using the Focalist handheld robotic system have been successfully performed, Mendaera announced in a news release.¹ The device was used to obtain kidney access during percutaneous nephrolithotomy (PCNL).

The procedures were performed by Karen L. Stern, MD, of the Mayo Clinic and presented during the 2025 World Conference on Endourology and Uro-Technology (WCET) in Phoenix, Arizona.

According to Mendaera, “The Focalist System combines handheld robotics, real-time ultrasound, and advanced software to enable precise, repeatable instrument placement.”The device obtained FDA clearance in the US in July 2025 for use in instrument placement of common interventional devices in adult and pediatric patients.²

“I was thrilled to be the first in the world to use the Focalist System,” said Stern in the news release.¹ “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.”

In addition to the handheld robotics and ultrasound imaging, the device features touchscreen targeting, robotic needle positioning, and continuous needle depth-tracking. According to Mendaera, these features enable a reproducible procedure experience.²

These first PCNL procedures mark the start of a limited US launch of the device for urology procedures in the US. The company plans to expand utilization across 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, in the news release.¹ “We’re proud to partner with Dr. Stern as she pioneers ultrasound-guided access in urology. We believe Focalist will empower more health care 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 health care system.”

REFERENCES

1. Mendaera announces world’s first procedures with Focalist handheld robotic system. News release. Mendaera. September 11, 2025. Accessed September 12, 2025. https://www.mendaera.com/press-releases/mendaera-announces-worlds-first-procedures-with-focalist-tm-handheld-robotic-system

2. Mendaera receives FDA 510(k) clearance for handheld robotic system. News release. Mendaera. July 8, 2025. Accessed September 12, 2025. https://www.mendaera.com/press-releases/mendaera-receives-fda-510-k-clearance-for-handheld-robotic-system