Biobot Surgical’s Robotic Prostate Biopsy/Ablation Needle Guidance Earns FDA Nod

Singapore-based Biobot Surgical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its iSR’obot Mona Lisa 2.0, a robotic-assisted transperineal needle-guidance system. The technology helps urologists plan and position one or multiple needles during image-guided diagnostic and interventional prostate procedures.
 
Based on a customized needle plan, iSR’obot Mona Lisa 2.0 automatically supports needle positioning during transperineal prostate biopsy and prostate cancer ablation.
 
“The Mona Lisa system was conceptualized and engineered to position biopsy or treatment needles transperineally,” Biobot Surgical CEO Sim Kok Hwee told the press. “The advantages of transperineal procedures are lower infection rates and better coverage of the anterior zone compared to transrectal procedures. In addition, most ablation procedures are also carried out transperineally. The Mona Lisa system simplifies needle positioning by providing robotic assisted guidance for the insertion.”
 
The next-gen system features a detachable needle guide to hold a biopsy needle or multiple ablation needles. Needle locations for ablation can be visualized and planned, and the target location can be readjusted should the needle deflect.
 
The system contains MR.-ultrasound image-fusion prostate biopsy tech, with proprietary dual-cone needle trajectory tech to extract multiple biopsy core through the same needle entry points. The first-gen iS’Robot Mona Lisa is sold in Europe, Australia, and Asia.