Press Releases
Press Releases
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July 8, 2025
Mendaera Receives FDA 510(k) Clearance for Handheld Robotic System
The platform combines real-time ultrasound with a robotic arm to increase the precision of common needle-based procedures, while reducing the costs of care delivery and supporting better patient outcomes
Mendaera, Inc., a healthcare technology company, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its handheld robotics platform which combines real-time ultrasound imaging with a robotic arm designed to help clinicians place needles for common procedures more precisely and consistently. Mendaera’s technology is cleared for commercial use in all ultrasound-guided needle-based procedures, with an initial rollout in urology.
In the United States, an estimated 200 million needle-based procedures are performed annually. However, just 20% of providers perform the majority of these interventions, in part due to the complexity of mastering the required skillset. With traditional freehand techniques, even experienced specialists achieve only a 37% first-stick accuracy rate, which means health systems often need to rely on only the most experienced specialists to perform needle-based procedures. This, in turn, can increase the cost of care delivery, lead to critical levels of provider burnout, and to delays in patient care.
“Surgical robots have long been confined to the operating room due to size and cost, limiting their widespread adoption,” said Josh DeFonzo, Co-founder and CEO of Mendaera. “With Mendaera’s FDA clearance, higher-frequency procedures – like biopsies, nerve blocks, and placing catheters – can be performed in a diversity of care settings, allowing healthcare systems to improve the quality of care and deliver it more efficiently.”
Mendaera’s provider-guided robot attaches to an ultrasound probe, freeing up the other hand to choose a target by tapping it on a touchscreen. The robot then calculates the optimal trajectory and depth of the needle, compensating for patient and provider motion, and when the provider is ready, they deploy the robot to insert the needle.
Early studies demonstrate the system’s significant impact on precision, with novice providers improving first-attempt success rates from 12% to 73% and experienced providers improving from 37% to 83%.
"Inserting an instrument into a patient using ultrasound has long been akin to finding a needle in a haystack,” said Jason Wilson, Ph.D., Co-Founder and Chief Technology Officer of Mendaera. “Mendaera’s combination of handheld robotics and features like anatomy recognition, instrument depth tracking, and telepresence are designed to empower clinicians of all skill levels to confidently achieve first-stick success, freeing experienced specialists for the most intricate cases where their expertise is indispensable."
The Mendaera system will initially be rolled out to support the treatment of Percutaneous Nephrolithotomy (PCNL), which requires a minimally invasive procedure to remove kidney stones. Due to wide variations in individual kidney shape and anatomy and the need to precisely locate the kidney’s collection site, this procedure requires meticulous technique and experience to avoid damaging surrounding tissues.
“There is an immediate need for technology that can improve the accuracy and efficiency of common urological procedures like PCNL,” said [Dr. Stern/Chi] “By incorporating robotics like Mendaera, we can have a significant and immediate impact on healthcare system operations and increase positive patient outcomes.”
The company also plans to expand its platform’s application to other areas, such as interventional radiology, emergency medicine, and anesthesia.
For more information, please visit www.mendaera.com
About Mendaera
Mendaera’s vision is to digitize clinical judgment and technical expertise, making high-quality care available for every patient at every care facility. Its FDA-cleared platform combines robotics, real-time imaging, and connectivity to enable intervention at scale. Based in Silicon Valley, Mendaera is backed by leading investors and includes a leadership team successful in taking early-stage medical technology companies through to successful exits including Auris Health.
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