Needle-Based Intervention Robot Compatible with both Fluoroscopy and CT

Micromate has received an additional 510(k) clearance, which authorizes the robotic system’s commercial sale in the U.S. for percutaneous procedures guided by CT optical navigation. These procedures include biopsies and ablations used for diagnosing and treating conditions affecting the chest, abdomen, and musculoskeletal systems. This new FDA approval extends Micromate's range of applications, building on its existing clearance since 2021 in the United States for any percutaneous needle-based interventions conducted under real-time imaging via Cone-Beam Computed Tomography (CBCT), Fluoro CT, or a Fluoroscope. The miniature robot has also gained approval for compatibility with third-party navigation systems.

Micromate's planning and navigation station, which facilitates a CT scanner-based navigation process, was deployed for the first time in the Netherlands a year ago. Since then, it has been used regularly at various clinical sites across Europe for indications and procedures that require needles or instruments from 8-21G.

“This clearance is a long-awaited milestone for us, and it allows us to meet the growing demand for our system in the US,” said Pedro Costa, CEO of Interventional Systems. “We are already in the process of executing the first installations overseas, bringing the benefits of our robotic platform to US patients. We designed Micromate for versatile use within the scope of work of any IR/IO specialist, and we expect it to help hospitals gain efficiency in an era where both demand for precision and staff shortages are pressing concerns.”

“The clinical data reviewed by the FDA as part of our submission demonstrates that we provide high accuracy in all major anatomical regions, making procedures faster and safer,” added Srdjan Milosavljevic, Chief Technology Officer of Interventional Systems. “We believe that both large institutions and ambulatory centers can benefit from Micromate’s unique features, and we will make sure we will always keep cost-effectiveness in mind when building on our innovative robotic technology.”

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