Mendaera, a robotics company, announced it has been granted FDA 510(k) clearance for Focalist, a handheld robotic system, which aims to combine handheld robotics with real-time imaging to enable clinicians to place needles with precision.
Mendaera said the system integrates robotics, ultrasound imaging and advanced software to make medical procedures more accessible.
Among Focalist’s features are touchscreen targeting, robotic needle positioning and continuous needle depth tracking, enabling a reproducible procedure experience.
While needle placement is used for a variety of procedures and in a broad range of clinical settings, the initial focus of the system will be in urology. Full commercialization is 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,” Josh DeFonzo, cofounder and CEO of Mendaera, said in a statement.
“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.”
THE LARGER TREND
In April, Mendaera collaborated with fellow needle company Cook Medical to offer Cook’s needles as an option combined with the Mendaera robot.
The collaboration aims to create “cutting-edge” tools for needle-based interventions in urological procedures. Cook’s EchoTip technology was integrated into Mendaera’s instrumentation offerings.
In 2024, EchoNous, a company specializing in portable ultrasound technology, partnered with Mendaera, enabling compatibility between EchoNous’ portable ultrasound machine Kosmos and Mendaera’s handheld robotic interventional platform.
That same year, Mendaera announced the closing of a $73 million Series B funding round. The funds were used to further the company’s efforts to scale robotics and AI across mainstream medical procedures.
Mendaera acquired Avail Medsystems’ telepresence technology last year. Mendaera utilized its expanded portfolio to increase patient access to interventions to help improve patient care within healthcare systems.
In 2023, Mendaera secured $24 million in Series A funding in a round led by Lux Capital.
The company said it would use the funds to open a production facility to complete development of its technology and obtain FDA clearance.
