EU approves Mona Lisa 2.0 robotic system for prostate cancer

The Mona Lisa 2.0 has been granted European CE certification for robotic-assisted biopsy and tissue ablation in prostate cancer, Biobot Surgical, the developer of the platform, announced in a news release.¹

The Mona Lisa 2.0 builds off the team’s first-generation Mona Lisa model.

With CE mark approval, the device is cleared for use in 32 countries across Europe.

The Mona Lisa 2.0 platform has been previously approved in the US, Australia, and Singapore. The company is also anticipating a regulatory decision from China’s National Medical Products Administration this year.²

"The CE Certification of Mona Lisa 2.0 is a significant milestone for Biobot Surgical," said Albert Lee, CEO of Biobot Surgical, in the news release.¹ "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."

The Mona Lisa 2.0 is equipped with advanced positioning to allow for improved precision during prostate interventional procedures. This enhancement accounts for shifts during the procedure and enables users to adjust the prostate model and planned needle locations in real time.

The platform also has a new software capability that “allows urologists to adjust needle trajectory deviations caused by tissue heterogeneity or needle tip design, ensuring precise alignment with the planned target,” the company noted.

The multi-needle insertion on the robotic system also enables enhanced precision. On the system’s visualization, Biobot added in the news release, “The visual overlays of lesion margin and simulated ablation zone help with targeting of the region of interest while avoiding critical structures.”

The Mona Lisa 2.0 builds off the team’s first-generation Mona Lisa model, which was launched in 2017 for targeted prostate biopsies. According to Biobot Surgical, the team also plans to release an additional surgical platform, Mona Lisa Access, in 2025.²

References

1. Biobot Surgical's Mona Lisa 2.0 secures CE Certification: Transforming prostate care with precision, efficiency, and versatility for prostate biopsy and ablation. News release. Published online and accessed January 14, 2025. https://www.prnewswire.com/news-releases/biobot-surgicals-mona-lisa-2-0-secures-ce-certification-transforming-prostate-care-with-precision-efficiency-and-versatility-for-prostate-biopsy-and-ablation-302349925.html

2. Innovation pipeline. Biobot Surgical. Accessed January 14, 2025. https://biobotsurgical.com/#innovation-pipeline