XACT Robotics received clearance from the FDA for the second generation of its hands-free system for image-guided percutaneous procedures, such as biopsies, drainages and ablations.
The former Fierce 15 winner plans to launch its new ACE system later this year, with an initial focus on interventional radiologists for CT-guided surgeries. It combines a robotically guided system with procedure planning and navigation support.
The compact, mobile device starts with patient scans and physician guidance, then automatically carries out the needle insertion procedure. It can also be performed under remote supervision, allowing clinicians to reduce their radiation exposure by remaining outside the procedure room.
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“Following the clearance of our first robotic system last year, and the successful experience we have had to date with the medical centers using our system, we are excited to leverage our recent ACE Robotic System clearance to scale up our commercialization efforts and enable other centers to access our technology and enhance their clinical and economical outcomes,” said XACT CEO Chen Levin.
The Israel- and Massachusetts-based company first received an FDA clearance for its robotic system in October 2019, also for CT-guided interventions. The company said it aims to add MRI, ultrasound and fluoroscopy imaging to its capabilities over the coming years.