XACT Robotics receives FDA clearance for remote control unit
XACT Robotics, developer of a robotic system for interventional procedures, has seen its ACE Xtend Remote Control Unit receive U.S. Food and Drug Administration (FDA) clearance, allowing users to robotically insert and steer the XACT ACE Robotic System remotely from the control room.
The first-of-its-kind feature for CT-guided percutaneous procedures is designed to improve physician workflows while limiting physician and other users’ exposure to radiation and reduce physical strain.
Shai Meltzer, CEO of XACT Robotics, said: “The XACT ACE Robotic System has already allowed users to make percutaneous procedures, such as ablations, drainages and biopsies, more accurate, consistent and efficient. The addition of ACE Xtend has the potential to further increase efficiencies for the care team with a streamlined workflow that helps reduce the time in which physicians and other users are exposed to harmful radiation during standard procedures.”
Jeffrey Solomon, MD, vice president of medical affairs at XACT, added: “Interventional radiology is among the medical specialties that are facing a physician shortage in the coming years and technologies that can improve their efficiencies are crucial. By equipping different users with tools that can standardise the procedure and potentially shorten procedure times, we can maximise the number of patients they see and help to mitigate the gap between the patient population and the physician population.”
The XACT ACE Robotic System combines image-based planning and monitoring with patented S-Drive technology, which enables the system to quickly adapt from a linear to a non-linear trajectory with its robotic insertion and steering of instruments during interventional percutaneous procedures.
It has been proven to achieve 1.7mm tip to target average accuracy upon first insertion based on data obtained from company clinical studies for biopsy procedures. By providing accurate and actionable results for medical diagnosis, the system aims to enhance early detection and improve patient outcomes.