The Most Advanced Robotic HIFU Platform Controlled by Urologists

Focal One
Robotic HIFU

Focal One Robotic HIFU is designed for urologists to perform focal ablation of prostate tissue. This innovative platform combines the latest in robotics, HIFU Energy delivery, advanced imaging, and ergonomic design.

Product Overview

Robotic Positioning System provides multi-axis sub-millimeter robotic movements and automatic safety features.

Dynamic Focusing Probe combines high-resolution real-time ultrasound imaging with precise HIFU energy delivery, resulting in extended treatment range and optimized treatment times.

HIFUsion® software allows urologists to import MRI or 3D biopsy maps at the time of treatment to establish precise contours around the target tissue and perform focused ablation.

Integrated Workstation features a flexible cart-based system, compatible with standard OR beds, and an ergonomic design ensuring surgeon comfort and efficient workflow.

New Focal One i

New System
Advanced Features

• Expanded HIFUsion® Capabilities
• Streamlined Treatment Workflows
• Embedded Video Content Library

• Treatment Streaming and Recording*
• Remote Proctoring & Telecollaboration*
• Endometriosis Treatment Ready* 

*Conditions Apply

New System
Advanced Features

• Expanded HIFUsion® Capabilities
• Streamlined Treatment Workflows
• Embedded Video Content Library

• Treatment Streaming and Recording*
• Remote Proctoring & Telecollaboration*
• Endometriosis Treatment Ready* 

*Conditions Apply

Focal One i HIFUsion software integrates advanced diagnostic imaging and biopsy map information with real-time ultrasound to provide accurate treatment planning. By incorporating HIFUsion’s expanded capabilities, urologists can precisely contour the target treatment area and avoid critical structures. HIFUsion is an open-platform concept that uses the latest DICOM standard and expands patient-specific imaging compatibility as well as AI-driven and intelligent algorithms.

Focal One i HIFUsion software integrates advanced diagnostic imaging and biopsy map information with real-time ultrasound to provide accurate treatment planning. By incorporating HIFUsion’s expanded capabilities, urologists can precisely contour the target treatment area and avoid critical structures. HIFUsion is an open-platform concept that uses the latest DICOM standard and expands patient-specific imaging compatibility as well as AI-driven and intelligent algorithms.

HIFUsion® Software
Harnessing the Most Advanced Diagnostic Imaging

new feature highlights

PSMA PET Integration allows clinicians to import and fuse PSMA PET images with Focal One’s best-in-class live ultrasound. This enables precise, personalized treatment plans leveraging the latest patient diagnostic imaging information.

Streamlined Workflow within the new HIFUSion software interface offers a streamlined, step-by-step guided workflow that improves fusion accuracy, reduces distortion, and ensures consistency across treatments. The result is greater surgeon confidence and enhanced efficiency in the OR.
Embedded Video Library provides in-system video content that supports real-time learning, giving users access to procedural refreshers and best practices on demand.

Designed for Collaboration and Future Indications

Focal One i offers treatment streaming and video recording support to enhance education and collaboration through remote proctoring and peer-to-peer support. It allows collaboration with peers worldwide, expanding patient access regardless of location.

The Focal One i is designed to support additional indications, including endometriosis. In March 2025, Focal One Robotic HIFU System received CE Mark certification for the treatment of posterior deep endometriosis infiltrating the rectum and surrounding structures.

Focal One Robotic Positioning Advantages

Focal One 2025_V3_sonde_72dpi

Complete Freedom of movement along five axes (3 linear, 2 rotational), offering both manual and motorized positioning.

Automatic Probe Positioning for optimal precision and protection of the rectal wall throughout HIFU energy delivery.

Robotic Execution of planned ablation is performed with unparalleled accuracy, ensuring safe and effective outcomes.

Automated
Safety
Features

Rectal Cooling System allows real-time monitoring and control of the temperature of the patented Ablasonic® cooling liquid.

 

Patient Movement Detector automatically triggers to halt treatment if the patient movement is detected.

 

Rectal Wall Positioning system monitors the rectal wall position in real time on the ultrasound image and automatically re-adjusts it’s position as needed.

Automated
Safety
Features

Rectal Cooling System allows real-time monitoring and control of the temperature of the patented Ablasonic® cooling liquid.

 

Patient Movement Detector automatically triggers to halt treatment if the patient movement is detected.

 

Rectal Wall Positioning system monitors the rectal wall position in real time on the ultrasound image and automatically re-adjusts it’s position as needed.

Dynamic Focusing Probe combines high resolution real-time ultrasound imaging with precise HIFU energy delivery resulting in expanded reach and fastest radiation-free-prostate-treatment.

Dynamic Focusing Probe Technology

Dynamic Focusing Probe Technology

Patented dynamic focusing probe technology enables real-time imaging during treatments with the highest-quality ultrasound imaging transducer on any HIFU system. This technology provides precise energy delivery in 5mm increments up to 40mm in anterior to posterior length, which expands the distance previously available in transrectal HIFU technology.

Dynamic Focusing Probe combines high resolution real-time ultrasound imaging with precise HIFU energy delivery resulting in expanded reach and fastest radiation-free-prostate-treatment.

Dynamic Focusing
Probe Technology

Patented dynamic focusing probe technology enables real-time imaging during treatments with the highest-quality ultrasound imaging transducer on any HIFU system. This technology provides precise energy delivery in 5mm increments up to 40mm in anterior to posterior length, which expands the distance previously available in transrectal HIFU technology.

Unique design Drives patient outcomes

Focal One® Robotic HIFU combines multi-axis, sub-millimeter robotic positioning with patented Dynamic Focusing Probe Technology to deliver precise HIFU energy.
The multi-axis robotic positioning system delivers sub-millimeter accuracy with five degrees of freedom, ensuring optimal probe placement for safe, effective energy delivery.

The dynamic focusing probe automatically adjusts the intensity and focal depth to deliver pinpoint ablation throughout the targeted tissue. 

 

This unique integrated design allows urologists to target the diseased portion of the prostate precisely while sparing healthy tissue and preserving patients’ quality of life.

Unique design Drives patient outcomes

Focal One® Robotic HIFU combines multi-axis, sub-millimeter robotic positioning with patented Dynamic Focusing Probe Technology to deliver precise HIFU energy.
 
The multi-axis robotic positioning system delivers sub-millimeter accuracy with five degrees of freedom, ensuring optimal probe placement for safe, effective energy delivery.
 
The dynamic focusing probe automatically adjusts the intensity and focal depth to deliver pinpoint ablation throughout the targeted tissue.
 
This unique integrated design allows urologists to target the diseased portion of the prostate precisely while sparing healthy tissue and preserving patients’ quality of life.
Prostate Treatment

Discover the Benefits of Focal One

Discover the Patient Benefits of HIFU and how you can change your prostate health without changing your life. Focal One HIFU Prostate Tissue Ablation allows patients to maintain their quality of life with minimal side effects. 

Prostate Treatment

How Patients Benefit from Focal One

Discover the Patient Benefits of HIFU and how you can change your prostate health without changing your life. Focal One HIFU Prostate Tissue Ablation allows patients to maintain their quality of life with minimal side effects. 

Comparison of urinary continence and erectile function outcomes at 12 months between HIFU and surgery. Urinary continence: 64% for HIFU, 53% for surgery. Erectile function decrease: -7 for HIFU, -13 for surgery.

IN THE NEWS

Landmark HIFI Study Publication Demonstrates Positive Outcomes With Focal One® Robotic HIFU Versus Surgery In The Management Of Prostate Cancer