Focalist is designed to be accessible across specialties and to help meet the growing demand for needle-based interventions. | Source: Mendaera
Mendaera Inc. today announced that it has received U.S. Food and Drug Administration 510(k) clearance for its Focalist handheld robotic system. The San Mateo, Calif.-based company said it designed Focalist to simplify and enhance the precision of ultrasound-guided needle placement — a technically demanding procedure performed across many specialties and care settings.
“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,” stated Josh DeFonzo, co-founder and CEO of Mendaera.
“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,” he added. “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.”
Mendaera claimed that it is building a new category of handheld robotics to make precision surgery more accessible across healthcare. The San Mateo, Calif.-based company is backed by leading investors and said its leadership team has been successful in taking medical technology companies startups to successful exits, such as Auris Health.
In September 2024, Mendaera raised $73 million in Series B funding. Threshold Ventures led the funding round. Lux Capital, PFM Health Sciences, and Fred Moll, the founder of Intuitive Surgical and Auris Health, also participated in the round.
Mendaera targets common but difficult procedures
Image-guided procedures involving the placement of needles or other interventional instruments are a cornerstone of medical care. They’re used in hundreds of millions of patient encounters globally each year.
Despite being commonplace, the success of these procedures is highly dependent on the operator’s coordination, spatial judgment, and experience, noted Mendaera. These skills are hard to acquire and vary significantly across providers and institutions, leading to inconsistent patient experiences and system-wide inefficiencies, it said.
The company said it designed Focalist to support precise and consistent needle placement across a breadth of users and clinical settings. The system integrates handheld control, real-time ultrasound imaging, and advanced software. The robot also features touchscreen targeting, robotic needle positioning, and continuous needle depth-tracking to enable reproducible minimally invasive procedures.
“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,” he said.
Focalist proceeds toward commercialization
The FDA has cleared Mendaera’s Focalist system for use in the U.S. in diagnostic or therapeutic procedures with pediatric and adult patients.
With the clearance, Mendaera is starting a limited launch of Focalist with select medical institutions this year. This launch will initially focus on uses in urology, such as supporting procedures like percutaneous nephrolithotomy (PCNL), where precise access to the kidney is required.
The company plans to later expand to other specialties. Mendaera said it anticipates full commercialization of the Focalist system in 2026.
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