FDA awards market clearance to robotic interventional device

FDA awards market clearance to robotic interventional device

Time Stamp: October 20, 2023 6:37 AM
Source Node: 2950604

Interventional Systems’s Micromate is intended for use use in procedures such as biopsies and ablations as well as to diagnose and treat conditions in the chest, abdomen, and musculoskeletal structures. Credit: Shutterstock / Terelyuk

Australian robotics company Interventional Systems has received approval from the US Food and Drug Administration to bring its needle-based intervention robot, Micromate, to market.

Micromate has been awarded 510(k) clearance, allowing the commercial sale of the robotic system in the US for percutaneous procedures using CT optical navigation.

The device is intended for use in procedures such as biopsies and ablations, as well as to diagnose and treat conditions in the chest, abdomen, and musculoskeletal structures.

Interventional Systems CEO Pedro Costa said: “This clearance is a long-awaited milestone for us, and it allows us to meet the growing demand for our system in the US.

“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.”

This new clearance expands the devices’ remit as it has been available in the US since 2021 for percutaneous needle interventions performed under live imaging using cone-beam computed tomography (CBCT), fluoro CT, or a fluoroscope.

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The company has also said that the device has also made headway in Europe, after having been successfully deployed at the Netherlands-based St Antonius Hospital, used in a number of procedures requiring needles or instruments from 8-21G.

Interventional Systems chief technology officer Srdjan Milosavljevic said: “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.

“We believe that both large institutions and ambulatory centres 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.”

It comes after French robotics company Robocath released data from trials of its R-One robotic carotid stenting device, detailing a 100% success rate in single-arm, non-randomised clinical trials.

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