Former Fierce 15 winner XACT Robotics collected its second FDA clearance of the year for its palm-sized interventional device.
The new green light covers remote control hardware that allows the miniature robot to be steered completely from outside the operating room, which the company said in a release will help surgeons avoid the radiation and physical strain that comes with performing real-time, image-guided procedures.
Placed above the patient, XACT’s ACE system can align and insert needles and probes for a wide range of tasks that require precision and a steady hand, such as percutaneous biopsies, draining fluids and the targeted delivery of drugs.
This past May, the FDA opened up the device to CT-guided ablation procedures for assistance in burning out or freezing clustered tumor cells in organs such as the kidneys, liver or adrenal glands without requiring open surgery.
“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,” Jeffrey Solomon, XACT’s vice president of medical affairs, said in the release.
“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,” Solomon added.
The latest generation of the compact, mobile device was first cleared by the FDA in 2020. After starting with patient scans and physician guidance, the ACE robot automatically carries out the needle insertion procedure. It can also adjust the angle and path of the probe in a non-linear manner if the target within the body moves during the procedure, whether due to the insertion of the instrument or the patient’s breathing.