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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

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.”

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.