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XACT Robotics Wins FDA Clearance that Expands Support for Ablation Procedures


XACT Robotics® has today announced that it has received US Food and Drug Administration (FDA) clearance for a modification to its cleared XACT ACE® Robotic System designed to support robotic insertion and steering of ablation probes during ablation clinical procedures.  This clearance expands the company’s already broad indication for CT-guided percutaneous procedures with over 200 clinical cases performed to date in multiple medical centers.

“Ablation procedures are challenging to many users in terms of the accuracy and time required to place the ablation probes” said Harel Gadot, founder and executive chairman of XACT Robotics®. “The proven ability of our system to reach relatively small targets, regardless of target movement or obstacles, with unparalleled accuracy and one insertion to target will provide better patient outcomes with greater efficiencies. Moreover, with the addition of the newly cleared ablation capabilities, we can now provide even more value to our partners by increasing the utilization of our system.”

The comprehensive XACT ACE® Robotic System is the first and only technology that combines image-based procedure planning and real time monitoring with hands free precise robotic insertion and non-linear steering. Using the XACT ACE® Robotic System for ablation probe insertion and steering, health systems now have the potential to save time with fast and accurate probe placement​, contributing to the overall procedure efficiency and success. The proprietary robotic insertion and non-linear steering precisely delivers instruments to a desired target in the body—overcoming the size, depth, movement, or obstructions that may be in the path. The system has been proven to achieve unparalleled 1.7mm tip to target average accuracy upon first insertion, with a less than 8.5-minute average skin to target time. This has the potential to enhance a user’s ability to provide more timely and accurate diagnoses and treatment for patients, helping to reduce the “watchful waiting” period and improve outcomes.

XACT Robotics® will showcase its new capability at the Society of Interventional Radiology’s Annual Scientific Meeting, which takes place in Boston from June 11-16 in booth 411. In addition, the SIR Foundation Resident Research Award winning abstract titled “Safety and Accuracy of a Hands-free Robotic System for CT-guided Needle Insertion in Percutaneous Procedures” will be presented by Beth Israel Lahey Health and includes data supporting the system’s performance during clinical procedures.

Source: XACT Robotics

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