Approval in Europe adds to existing approvals in the U.S., Australia and Singapore, according to a news release. The company says this milestone paves the way for the utilization of Mona Lisa 2.0 across 32 additional countries.
Biobot designed Mona Lisa as a robotic-assisted transperineal needle positioning device for prostate disease management. It delivers a precision percutaneous approach to these procedures. The company hopes to use funds to bring it into the field of benign prostatic hyperplasia (BPH) as well.
Mona LIsa 2.0 supports precise targeting and flexibility in prostate biopsies and ablations. It enables the adjustment of the prostate model and needle locations in real-time to account for shifts during the procedure. The platform supports precision in both diagnostic and therapeutic interventions and ensures accurate treatments even in dynamic scenarios.
Biobot said it incorporated a new software capability that allows urologists to adjust needle trajectory deviations caused by tissue heterogeneity or needle tip design. This ensures precise alignment with the planned target. The resulting increased accuracy leads to more reliable biopsies and treatments, improving diagnostic confidence and reducing risks.
Additionally, the system’s multi-needle insertion optimizes efficiency during complex interventions. This reduces manual effort and enhances workflow precision. Visual overlays of lesion margin and simulated ablation zone help target the region of interest while avoiding critical structures.
“The CE Certification of Mona Lisa 2.0 is a significant milestone for Biobot Surgical,” said Albert Lee, CEO of Biobot Surgical. “With its advanced capabilities, Mona Lisa 2.0 is set to redefine prostate care across Europe. Urologists can now leverage its unmatched precision and adaptability to deliver superior patient outcomes.”
