FDA clears miniature Micromate robot for CT-guided needle biopsies, interventional procedures

Interventional Systems’ small robot aims to make a big impact. The company’s Micromate system for guiding needle-based procedures has received a new clearance from the FDA that broadens its use with CT imaging. 

The shoebox-sized device attaches to the scanner’s table and sits above the patient to help align tools such as biopsy and ablation probes while allowing providers to cut back on their radiation exposure.

“This clearance is a long-awaited milestone for us, and it allows us to meet the growing demand for our system in the U.S.,” Pedro Costa, CEO of Germany-based Interventional Systems, said in a statement. “We are already in the process of executing the first installations overseas, bringing the benefits of our robotic platform to U.S. patients.”

Micromate robot

Micromate first received a 510(k) clearance in 2021 for percutaneous procedures that use real-time fluoroscopy or C-arm cone-beam CT hardware. The joystick-equipped system is designed to be universally compatible with a surgeon’s own instruments.

“The clinical data reviewed by the FDA as part of our submission demonstrates that we provide high accuracy in all major anatomical regions, making procedures faster and safer,” said Chief Technology Officer Srdjan Milosavljevic.

To work with CT scanners, the Micromate employs its own planning and navigation console to plot out the course of the needle, along with a tracking camera that fits inside the gantry, allowing it to perform for lung, spleen or bone lesion biopsies, for example. 

According to the company, its robotic device was able to help reduce the need for multiple scans in a Netherlands hospital, requiring only an initial scan and a verification scan to enable image acquisition, trajectory planning, instrument alignment, lesion targeting and final confirmation.