Mona Lisa Prostate Puncture Robot

Mona Lisa became China’s first NMPA-approved robotic prostate puncture positioning system when it received market authorization in May 2023. Developed through joint venture Shanghai Intbot Robotics (a collaboration between MicroPort MedBot and Singapore’s Biobot Surgical), the system addresses accuracy and repeatability challenges in transperineal prostate biopsy for cancer diagnosis.

Product Overview

Prostate biopsy remains the gold standard for prostate cancer diagnosis, yet conventional manual techniques suffer from positioning variability, uneven sampling, and operator-dependent outcomes. Mona Lisa replaces manual needle guidance with robotic precision, integrating MRI-ultrasound fusion imaging to target suspicious lesions identified on multiparametric MRI.

The system completed China’s first multicenter clinical trial for prostate puncture robots in April 2022 at Nanjing Gulou Hospital, Xi’an Jiaotong University First Affiliated Hospital, and Subei People’s Hospital. Commercial launch occurred following NMPA approval in May 2023, with the official product launch event held at the 30th National Urology Academic Annual Conference (CUA 2023) in October 2023.

Key Features

Approved in China in May 2023, Mona Lisa combines MRI-ultrasound fusion with a two-point needling approach that reduces pubic arch interference and delivers more uniform prostate sampling.

• MRI-Ultrasound Fusion: Real-time fusion algorithms overlay MRI lesion data onto live ultrasound for targeted sampling
• Intelligent Planning Software: Preoperative planning with interactive adjustment enables customized biopsy protocols
• Motion Compensation: Automatic adjustment for patient movement maintains targeting accuracy
• Needle Offset Compensation: Algorithm corrects for needle deflection during tissue penetration
• Two-Point Needling Approach: Minimizes pubic arch interference and reduces incision count while achieving complete prostate coverage
• Full Reporting: Generates post-procedure reports with 3D images and clinical data

Technical Specifications

MicroPort MedBot’s Mona Lisa uses real-time MRI-ultrasound fusion, motion compensation, and needle offset correction across a mobile cart-and-robotic-arm system.

Clinical Applications

Mona Lisa is indicated for robot-assisted transperineal prostate biopsy guided by transrectal ultrasound. Clinical applications include:

Diagnostic Biopsy: Targeted sampling of MRI-suspicious lesions for prostate cancer diagnosis Systematic Biopsy: Thorough prostate sampling using robotically guided template approach Focal Therapy Guidance: Following successful validation in January 2023, Mona Lisa demonstrated capability for guiding cryoablation procedures in combination with ablation platforms

The world’s first robotic-positioned prostate cancer cryoablation was completed at Nanjing Gulou Hospital using Mona Lisa in combination with AccuTarget MediPharma’s cryoablation device, validating the platform’s utility beyond diagnostic biopsy.

Regulatory Status

Note: Mona Lisa 2.0 (treatment-focused variant) has separate FDA, CE, TGA, and HSA clearances per Biobot Surgical.

Joint Venture Structure

Shanghai Intbot Robotics Co., Ltd. combines:

• Biobot Surgical Pte. Ltd. (Singapore): Core iSR’obot platform technology and international regulatory portfolio
• MicroPort MedBot (China): Clinical trial infrastructure, manufacturing, and China market access

This partnership enabled rapid clinical validation and regulatory approval while leveraging established international technology.

Clinical Validation

The registered clinical trial, led by Professor Hongqian Guo at Nanjing Gulou Hospital, demonstrated Mona Lisa’s performance advantages over manual biopsy:

• Improved positioning accuracy
• More uniform prostate sampling
• Reduced missed diagnoses
• Fewer punctures required
• Lower complication risk

These benefits translate to earlier prostate cancer detection and reduced patient discomfort during the diagnostic process.

Frequently Asked Questions

What is the advantage of robotic prostate biopsy?

Robotic guidance improves biopsy accuracy by precisely targeting MRI-identified suspicious areas, reducing false negatives from missed lesions. The systematic approach also ensures more complete prostate sampling compared to freehand techniques.

How does MRI-ultrasound fusion work?

Preoperative MRI images showing suspicious lesions are registered to live ultrasound during the procedure. The fusion algorithm overlays MRI targets onto the real-time ultrasound, allowing accurate needle guidance to specific locations identified on MRI.

Is Mona Lisa used only for diagnosis?

While the primary indication is diagnostic biopsy, Mona Lisa has been validated for guiding focal therapy procedures such as cryoablation. This expands utility from diagnosis to treatment planning and execution.