MendaeraA robotic company has announced that the FDA 510 (K) received approval for Focist, a handy robot system, which aims to combine the handheld robotics with real -time imaging to enable clinicians to place needles with precision.
Mendaera said that the system is integrating robotics, ultrasound and advanced software to make medical procedures more accessible.
One of the focalist’s characteristics is touchscreen targeting, robot positioning and continuous needle depth -Tracking, making a reproducible procedure experience possible.
Although needle installation is used for different procedures and in a wide range of clinical environments, the first focus of the system will be in urology. Full commercialization is expected in 2026.
“Accurate placement of needles to perform a wide range of procedures, organ access, biopsy, vascular access or therapy release, as examples, is a very challenging but fundamental technique that substantiates most journeys with patient care,” said Josh Defonzo, employee and CEO of Mendendera.
“Our mission is to ensure that these procedures are supplied safely and efficiently in the health care system by enabling more providers to perform these techniques. Robotics have shown that robotics increase the capacities in complex procedures and we are planning to show that the same can be true in daily care.”
The larger trend
In April, Mendaera worked together with colleague -Daaldbedrijf Cook Medical to offer the Cook’s needles as an option in combination with the Mendaera robot.
The collaboration is intended to create “advanced” tools for needle -based interventions in urological procedures. Cook’s Echotip technology was integrated into Mendaera’s instrumentation offerings.
In 2024, Echonous, a company that specializes in portable ultrasound technology, worked together with Mendaera, which made compatibility possible between the portable ultrasound of Echonous Cosmos and Mendaera’s Handheld Robotic interventional platform.
In the same year, Mendaera announced the closure of a B -financing round of $ 73 million. The funds were used to increase the efforts of the company to scale robotics and AI on the regular medical procedures of the company.
Mendaera took over the Telepresence technology from MedSystems last year. Mendaera used his extensive portfolio to increase patient access to interventions to improve patient care within health care systems.
Secure Mendaera in 2023 $ 24 million in Serie A financing in a round led by Lux Capital.
The company said it would use the funds to open a production facility to complete the development of its technology and obtain FDA approval.
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