Product profile
Focal One i Robotic HIFU System
Focal One is a robotic high-intensity focused ultrasound system used by FocalTherics for image-guided endometriosis and prostate-cancer treatment programs.
Facts
- Company
- FocalTherics
- Product type
- surgical_robot
- Status
- commercial
- Primary capability
- robotic HIFU therapy
- Website
- https://focalone.com/product-details/
About Focal One i Robotic HIFU System
Focal One combines real-time transrectal ultrasound with imported MRI and three-dimensional biopsy data. HIFUsion software overlays those sources so the physician can contour the target within the prostate. A five-axis robotic positioning system then places the probe with submillimetric accuracy, while the Dynamic Focusing Probe adjusts focal depth and delivers thermal ablation in 5 mm increments.
The urologist defines and supervises treatment and retains every clinical decision. Focal One can ablate approximately 30 cc per hour, with the complete setup, planning and treatment workflow typically lasting about 45–90 minutes. FocalTherics is also applying the underlying image-guided HIFU platform to endometriosis programmes, while the established commercial product and clinical documentation remain centred on prostate-tissue ablation.
Market context
HIFU, Focal One i, https://www.globenewswire.com/news-release/2026/06/30/3319551/9622/en/focaltherics-announces-successful-launch-of-first-commercial-endometriosis-focal-one-program-in-europe-with-treatment-of-initial-patients.html, 1800, 1803, 35aaa44151b1504ce962f573107ed8309ee1bbc4540b891928ce82d3e5040366, Robotic HIFU System, existing_category_first, https://focalone.com/wp-content/uploads/2026/03/FocalOne_i_Product_image_202603.png, https://focalone.com/product-details/, 2026-08-19, products/notion-missing-media/2026-07-30/batch6/focal-one-product-2026.png, 2026-07-30, official_product_image_uncropped, medical_robot, 2026-08-21, exact_current_generation_official_asset, Robotic HIFU System, medical_robot, not_other, robotic_hifu_system, medical_robot, controlled_category_mapping_2026-08-21, false
Summary
Type: Robotic HIFU system
Core: Focal One
Function: Therapeutic ultrasound
Audience: Hospitals
Specifications
- ablation_rate
- 30 cc/hour cc/h
- clinical_programs
- endometriosis and prostate cancer
- clinical_workflow
- Guided step-by-step HIFUsion and treatment workflow
- dynamic_focusing_depth
- Up to 40 mm anterior-to-posterior mm
- hifu_targeting_increment
- 5 mm
- imaging_compatibility
- PSMA PET; ExactVu Micro-Ultrasound; Unfold AI; OnQ Prostate; Koelis 3D biopsy maps; DynaCAD Urology
- modality
- robotic HIFU
- remote_collaboration
- Remote proctoring and collaborative procedures
- robotic_degrees_of_freedom
- 5 DOF
- typical_procedure_duration
- 45–90 minutes including setup and planning
- video_features
- Onboard video library; treatment streaming and recording
Operations
- Product detail
- HIFU, Focal One i, https://www.globenewswire.com/news-release/2026/06/30/3319551/9622/en/focaltherics-announces-successful-launch-of-first-commercial-endometriosis-focal-one-program-in-europe-with-treatment-of-initial-patients.html, 1800, 1803, 35aaa44151b1504ce962f573107ed8309ee1bbc4540b891928ce82d3e5040366, Robotic HIFU System, existing_category_first, https://focalone.com/wp-content/uploads/2026/03/FocalOne_i_Product_image_202603.png, https://focalone.com/product-details/, 2026-08-19, prod...