Designed to assist with needle-based interventions, the system aims to reduce user variability and enhance procedural efficiency.
Mendaera Inc, a healthcare technology company focused on developing robotics, has received US Food and Drug Administration (FDA) 510(k) clearance for its handheld robotic system, Focalist, designed to simplify and enhance the precision of ultrasound-guided needle placement.
Image-guided procedures involving the placement of needles or other common interventional instruments are a cornerstone of medical care, used in hundreds of millions of patient encounters globally each year. Despite being commonplace, successful procedures are highly dependent on the operator’s coordination, spatial judgment, and experience, according to a news release from Mendaera.
“Simplifying ultrasound-guided percutaneous access is one of the most impactful ways to improve efficiency, safety, and independence in urology and beyond,” says Gerhard J. Fuchs, MD, professor of clinical urology at the University of Southern California, in a release. “Ultrasound guidance offers the benefits of reduced radiation and better visualization of key anatomy, and when paired with robotics, can lower the barrier to precise access and instrument placement.”
The Focalist system integrates handheld robotics, real-time ultrasound imaging, and advanced software. Focalist features touchscreen targeting, robotic needle positioning, and continuous needle depth-tracking, designed to enable a reproducible procedure experience.
Mendaera will initiate a limited launch of its Focalist in select medical institutions in 2025, with an initial focus in urology. The company anticipates full commercialization of its Focalist system in 2026.
Photo caption: Focalist system
Photo credit: Mendaera Inc
