Interventional Systems Gains FDA 510(k) for Micromate Head-to-Toe Medical Robot

By Julie A. Vetalice

Interventional Systems Gains FDA 510(k) for Micromate Head-to-Toe Medical Robot

Interventional Systems announced Micromate™, the world's smallest robot for percutaneous procedures, received its FDA 510(k) clearance, allowing the robotics company to operate in the USA.

The robot, already operating in the American spine fusion landscape through its partner company, Fusion Robotics, can perform almost every non-invasive image-guided procedure.

Micromate is a table-mounted medical robot for interventional procedures with a universal instrument guidance solution that allows physicians to continue using their preferred surgical instruments. Targeting is performed under live-imaging using any Cone-Beam Computerized Tomography (CT), Fluoro CT or a Fluoroscope.

"We appreciate the partnership developed with the FDA to rigorously validate safety and accuracy. It is not trivial to develop a full-fledged robotic platform that puts surgeons in charge of so many different procedures with the same core technology, while ensuring a seamless integration into the clinical workflow", states Pedro Costa, Interventional Systems CPO.

"After a successful start with our partners in Europe and over ten years of experience in medical robotics, we decided it was about time we reached the other side of the pond", states Michael Vogele, Interventional Systems' founder and CEO. "We are sure our product is bound to democratize medical robotics in the US. The proven submillimeter accuracy and affordable price make it the most seasoned choice for any institution that is looking for new technology in order to improve the outcomes of interventional procedures", he adds.

The company plans to launch operations in the USA throughout the second-half of 2021 by launching centers of excellence for robotic-guided interventional procedures and establishing commercial partnerships with third-parties that look for a robotic offering to their customers.

Source: Interventional Systems

Product Labels: Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory