FDA clearance expands indications for Xact Robotics’ ablation system

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The ACE robotics system. | Credit: Xact Robotics

Xact Robotics announced that it has received FDA clearance for a modification to its Xact Ace robotic system for ablation procedures. Hingham, Massachusetts-based Xact Robotics’ FDA clearance allows for a modification to the already-cleared Xact Ace system, expanding the indication for CT-guided percutaneous procedures for the system designed to support robotic insertion and steering of ablation probes during ablation clinical procedures.

According to a news release, the Xact Ace robotic system has already been used in over 200 clinical cases to date across multiple medical centers.

The company said its Xact Ace system combines image-based procedure planning and real-time monitoring with hands-free precise robotic insertion and non-linear steering. It creates the potential to save time with fast and accurate probe placement.

Xact Ace has achieved a 1.7 mm tip-to-target average accuracy upon first insertion, with less than an 8.5-minute average skin-to-target time. The company said this potentially enhances a user’s ability to provide more timely and accurate diagnoses and treatment for patients, reducing the “watchful waiting” period and improving outcomes.

“Ablation procedures are challenging to many users in terms of the accuracy and time required to place the ablation probes,” Xact Robotics founder and Executive Chair Harel Gadot said in the release. “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.”

XACT Robotics won a 2022 RBR50 Robotics Innovation Award for its ACE Xtend. The remote control is an add-on solution that allows the company’s XACT ACE system for image-guided percutaneous procedures to be operated from a control room at a distance.