Mendaera has received FDA 510(k) clearance for its Focalist handheld robotic system, which enhances the precision of ultrasound-guided needle placement across multiple specialties.
The San Mateo, California-based company said Focalist combines handheld robotics, real-time ultrasound imaging and software that supports touchscreen targeting, robotic needle positioning and continuous depth-tracking. Mendaera plans a limited launch with select medical institutions in 2025, starting in urology procedures such as percutaneous nephrolithotomy, with full commercialization expected in 2026.
“Precise placement of needles to perform a wide range of procedures — organ access, biopsies, vascular access, or therapy delivery, as examples — is a very challenging, but foundational technique that underpins most patient care journeys,” CEO Josh DeFonzo said in a news release. “Our mission is to ensure that these procedures are delivered safely and efficiently across the healthcare system by enabling more providers with the confidence needed to perform these techniques. Robotics have been shown to increase provider capabilities in complex procedures, and we intend to demonstrate that the same can be true in everyday care.”
Image-guided procedures involving needles or other interventional instruments occur in hundreds of millions of patient encounters each year, according to the company. Operator skills can vary, leading to inconsistent patient experiences and system-wide inefficiencies.
“Simplifying ultrasound-guided percutaneous access is one of the most impactful ways to improve efficiency, safety, and independence in urology and beyond,” said Dr. Gerhard J. Fuchs, professor of clinical urology at the University of Southern California. “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. Mendaera’s platform represents a meaningful evolution — one with the potential to broaden access to minimally invasive procedures and elevate the standard of care.”
Focalist is cleared for use in pediatric and adult patients to guide standard interventional devices relative to an ultrasound transducer and image during diagnostic or therapeutic procedures.
