Biobot’s Robotic Prostate Biopsy and Cancer Ablation System Gets FDA Clearance

March 8, 2022

Singapore-based Biobot Surgical has received 510(k) clearance from the FDA for its iSR’obot Mona Lisa 2.0 robotic-assisted, needle-guidance system for use by urologists during prostate procedures.

The transperineal system features a detachable needle guide that holds a biopsy needle or multiple ablation needles, as well as visualization and planning of the needle locations for a prostate cancer ablation procedure. It can also readjust a target location if the needle deflects.

Transperineal procedures have lower infection rates and better coverage of the anterior prostate zone compared to transrectal procedures, the company said.

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