Focal One Robotic HIFU

The Most Advanced Robotic HIFU Platform Controlled by Urologists

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.

Focal one Advantages

Higher Precision

Dynamic Focusing Probe targets and delivers HIFU energy in 5 mm increments.
All motorized movements are robotically controlled with submillimetric accuracy.
HIFUsion proprietary software overlays MRI and/or 3D biopsy data for precise contouring.

Faster Treatment

Ablates 30 cc/hour, up to 3 times faster than other HIFU technologies.
Total procedure time including set-up and planning is typically 45 mins – 1.5 hr.
No need for manual readjustments, improving efficiency for the urologist and the OR operations.

Focal One Robotic Positioning Advantages

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.

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 & 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.

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 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.