Home FDA XACT Robotics ® Receives FDA Clearance for its ACE Xtend™ Remote Control Unit

XACT Robotics ® Receives FDA Clearance for its ACE Xtend™ Remote Control Unit

XACT Robotics ® Receives FDA Clearance for its ACE Xtend™ Remote Control Unit

XACT Robotics ®, developer of the world’s first and only comprehensive robotic system for interventional procedures, announced today that its ACE Xtend™ Remote Control Unit received 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.

“The XACT ACE Robotic System has already allowed users to make percutaneous procedures, such as ablations, drainages and biopsies, more accurate, consistent and efficient,” said Shai Meltzer, CEO of XACT Robotics. “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.”

“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,” said Jeffrey Solomon, MD, Vice President of Medical Affairs at XACT. “By equipping different users with tools that can standardize the procedure and potentially shorten procedure times, we can maximize the number of patients they see and help to mitigate the gap between the patient population and the physician population.”

The comprehensive XACT ACE Robotic System is the first and only technology that 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 precisely delivers instruments to the designated targets with unparalleled accuracy, unmatched consistency, and unlimited efficiency.

The XACT ACE Robotic System has been proven to achieve unparalleled 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.

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