iSR'obot Mona Lisa Prostate Biopsy Robot

Developed through the partnership between Shanghai Intbot and Biobot Surgical, the iSR’obot Mona Lisa represents China’s first NMPA-approved robotic system specifically designed for prostate biopsy in urology. The platform combines MRI-ultrasound fusion imaging with robotic needle guidance to improve diagnostic accuracy while reducing procedure-related complications.

Product Overview

The iSR’obot Mona Lisa addresses limitations of conventional manual prostate biopsy, which typically requires coordination between two or more surgeons and can result in inconsistent sampling, multiple punctures at the same location, and operator-dependent outcomes. By automating needle positioning through robotic guidance, the system aims to reduce the underdiagnosis rate while minimizing patient discomfort.

The platform integrates intelligent planning software, MRI-ultrasound fusion algorithms, and a precision robotic arm to enable targeted sampling of suspicious lesions identified on pre-procedural MRI. This targeted approach contrasts with systematic random biopsy patterns that may miss clinically significant cancers.

Key Features

MRI-Ultrasound Elastic Fusion: Real-time image fusion allows surgeons to correlate MRI-identified targets with live ultrasound during the procedure, enabling precise guidance to lesions regardless of their location within the prostate—apex, base, or peripheral zones.

Dual-Cone Needle Trajectory Technology: The proprietary needle path design enables extraction of multiple biopsy cores through the same skin entry points, reducing the number of punctures required while maintaining thorough sampling coverage.

Motion Compensation: Advanced algorithms filter out patient movement and tissue deformation during the procedure, maintaining targeting accuracy throughout needle insertion.

Transperineal Two-Point Approach: The novel access technique minimizes interference from the pubic arch while ensuring complete prostate coverage. The transperineal route also reduces infection risk compared to transrectal approaches.

Intelligent Planning Software: Preoperative planning tools enable surgeons to create and interactively adjust sampling strategies based on MRI findings, optimizing core distribution across suspicious regions.

Technical Specifications

iSR’obot Mona Lisa’s 1.0 mm mechanical positioning accuracy and transperineal two-point approach cover prostates up to 100 ml with MRI-ultrasound elastic fusion guidance.

Clinical Applications

The primary indication is robot-assisted transperineal prostate biopsy for prostate cancer diagnosis. The system supports both systematic and targeted biopsy protocols, with particular advantages in sampling MRI-visible lesions.

Extended applications include combination with ablation platforms for focal therapy. In January 2023, Nanjing Gulou Hospital completed the world’s first robotic-positioned cryoablation procedure for prostate cancer, combining the Mona Lisa with AccuTarget’s cryoablation system. This demonstrated the platform’s potential for diagnostic-therapeutic integration in localized prostate cancer management.

Clinical studies with the Mona Lisa platform have demonstrated an 81% higher clinically significant prostate cancer detection rate compared to cognitive fusion biopsy techniques. The transperineal approach combined with dual-cone needle technology has also shown minimized infection complications.

Regulatory Status

Note: CE, FDA, TGA, and HSA approvals are held by the technology partner Biobot Surgical for the global Mona Lisa platform. The China NMPA approval is held by Shanghai Intbot specifically for the Greater China market.

Frequently Asked Questions

How does Mona Lisa compare to manual prostate biopsy?

Manual biopsy relies on operator skill and typically uses a systematic pattern that may miss lesions. Mona Lisa enables MRI-targeted sampling with robotic precision, reducing sampling variability and improving cancer detection rates. Clinical data shows 81% higher detection of clinically significant prostate cancer compared to cognitive fusion approaches.

What is the advantage of transperineal over transrectal biopsy?

The transperineal approach (through the perineum) has significantly lower infection rates than transrectal biopsy because needles do not pass through the rectum. The Mona Lisa’s two-point entry design further minimizes patient trauma while maintaining complete prostate coverage.

Can Mona Lisa be used for treatment, not just diagnosis?

Yes. The platform can be combined with ablation devices for focal treatment of localized prostate cancer. The robotic positioning capabilities enable precise placement of cryotherapy or other ablation probes, as demonstrated in clinical applications combining Mona Lisa with cryoablation platforms.

How many procedures have been performed with Mona Lisa globally?

The Mona Lisa platform has been used in over 25,000 cases worldwide (including procedures in the United States), according to Biobot Surgical data as of 2024.