FDA clears hands-free XACT robotic system

1 November 2019 (Last Updated November 1st, 2019 10:08)

The US Food and Drug Administration (FDA) has granted marketing clearance to XACT Robotics’ hands-free robotic system for use in computed tomography (CT) guided percutaneous interventional procedures.

FDA clears hands-free XACT robotic system
XACT robotic system is designed to insert and steer different instruments during percutaneous interventional procedures. Credit: Sasin Tipchai from Pixabay.

The US Food and Drug Administration (FDA) has granted marketing clearance to XACT Robotics’ hands-free robotic system for use in computed tomography (CT) guided percutaneous interventional procedures.

The system uses a combination of image-based planning and navigation tools to insert and steer different instruments to the target location within the body.

The system can be used in an array of clinical applications and indications, according to Xact Robotics.

Furthermore, the robotic system’s relatively small footprint and mobile design allow care providers to cater to a variety of patient needs across multiple clinical areas, the company added.

XACT Robotics founder, executive chairman and president Harel Gadot said: “We are committed to redefining the way the entire medical community utilises robotics, beginning with interventional radiologists.

“Being the first to introduce a hands-free robotic system, we have the potential to provide significant clinical, technical and economic value while democratising interventional procedures.”

The XACT Robotic System is designed based on research by the Technion, Israel Institute of Technology professor Moshe Shoham, who founded Mazor Robotics, which was acquired by Medtronic last year.

A physician can use the XACT robot by attaching the desired tool to the system, which will perform the needle insertion and steering. The physician will be able to track the progress and correct any deviations.

The company noted that the system, which secured the European CE-Mark last year, compensates for breathing and patient movement during the procedure.

XACT intends to launch the system to some US radiology Centers of Excellence partners and debut it next month at the 2019 Radiological Society of North America conference (RSNA) in Chicago, US.

Last year, the company raised $5m in a Series C funding round to support the system’s launch in Europe, the US and Israel.