A New Era of Precision, Safety, and Personalized Prostate Care
Advancements in medical technology are rapidly transforming the way complex conditions are treated, and prostate care is no exception. Among the most significant innovations in this field is Focal One Robotic HIFU, an advanced robotic platform designed to deliver highly precise, minimally invasive focal therapy for prostate disease. By combining robotics, high-intensity focused ultrasound (HIFU), advanced imaging, and intelligent software, Focal One empowers urologists to treat only diseased tissue while preserving healthy structures and quality of life.
This next-generation system represents a shift away from traditional whole-gland treatments toward personalized, tissue-sparing therapy—a major step forward for both clinicians and patients.
Understanding Robotic HIFU Technology
High-Intensity Focused Ultrasound (HIFU) is a non-invasive therapeutic technique that uses focused ultrasound energy to generate heat and ablate targeted tissue without incisions or radiation. Focal One elevates this concept by integrating robotic control, real-time imaging, and intelligent treatment planning, enabling unmatched accuracy and consistency.
Unlike conventional approaches, Focal One is fully controlled by urologists, allowing them to plan, visualize, and execute treatment with confidence and precision.
Product Overview: An Intelligent, Integrated System
Focal One Robotic HIFU is designed as a complete ecosystem that supports every step of the procedure—from planning to execution.
Robotic Positioning System
The system features multi-axis robotic movement with sub-millimeter accuracy across five degrees of freedom (three linear and two rotational). These movements are fully motorized and include automatic safety features that ensure stable, reproducible probe positioning throughout treatment.
Dynamic Focusing Probe
At the heart of the system is the patented Dynamic Focusing Probe, which seamlessly combines:
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- High-resolution, real-time ultrasound imaging
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- Precise HIFU energy delivery in 5 mm increments
This allows urologists to treat a wider anatomical range with optimized energy control and reduced procedure time.
HIFUsion® Software
HIFUsion® software enables clinicians to import and fuse MRI scans and/or 3D biopsy maps directly into the live ultrasound image. This advanced fusion capability helps establish accurate contours around the target tissue, ensuring focused ablation exactly where it is needed.
Integrated Workstation
The flexible, cart-based workstation is compatible with standard operating room beds and designed with ergonomics in mind. The intuitive layout improves workflow efficiency while supporting surgeon comfort during procedures.
Key Advantages of Focal One Robotic HIFU
Higher Precision
Precision is central to the Focal One platform:
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- HIFU energy is delivered in controlled 5 mm treatment units
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- All movements are robotically executed with sub-millimetric accuracy
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- MRI and biopsy data overlay ensures exact tissue targeting
This level of precision allows clinicians to treat the diseased portion of the prostate while sparing surrounding healthy tissue.
Faster and More Efficient Treatment
Focal One is engineered for speed without compromising safety:
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- Capable of ablating up to 30 cc of tissue per hour
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- Procedures typically last 45 minutes to 1.5 hours, including setup and planning
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- Fully automated execution eliminates the need for manual probe adjustments
The result is improved operating room efficiency and a smoother experience for both clinicians and patients.
Advanced Robotic Positioning for Optimal Safety
The robotic positioning system offers:
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- Complete freedom of movement along five axes
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- Automatic probe positioning to protect the rectal wall
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- Robotic execution of the treatment plan with unparalleled accuracy
These features ensure that treatment is delivered safely, consistently, and exactly as planned.
New Feature Highlights Enhancing Personalization
PSMA PET Image Integration
Clinicians can now import and fuse PSMA PET images with live ultrasound imaging. This innovation supports highly personalized treatment planning by incorporating the latest diagnostic insights into the ablation strategy.
Streamlined HIFUsion® Workflow
The updated software interface provides a guided, step-by-step workflow that:
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- Improves image fusion accuracy
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- Reduces distortion
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- Ensures consistency across treatments
This enhances surgeon confidence and procedural reliability.
Embedded Video Library
An in-system video library offers real-time access to procedural refreshers and best practices, supporting continuous learning directly within the operating room
Designed for Collaboration and Future Applications
Focal One i expands the platform’s capabilities with:
- Live treatment streaming
- Video recording for education and training
- Remote proctoring and peer-to-peer collaboration
These features allow clinicians worldwide to share expertise, expanding access to advanced care regardless of location.
Importantly, the system is designed to support future clinical indications. In March 2025, Focal One Robotic HIFU received CE Mark certification for the treatment of posterior deep endometriosis, highlighting its versatility beyond prostate care.
Automated Safety Features for Patient Protection
Patient safety is reinforced through multiple automated systems:
- Rectal Cooling System for real-time temperature control
- Patient Movement Detector that pauses treatment if movement is detected
- Rectal Wall Positioning System that continuously monitors and adjusts probe position
These safeguards work together to minimize risk and enhance treatment confidence.
A Design That Improves Patient Outcomes
The unique integration of robotic precision and dynamic focusing technology allows urologists to:
- Precisely target diseased tissue
- Preserve surrounding healthy structures
- Reduce side effects
- Maintain patient quality of life
By focusing treatment only where necessary, Focal One supports better functional outcomes and faster recovery.
Clinical Recognition and Growing Evidence
Clinical studies continue to demonstrate positive outcomes with Focal One Robotic HIFU compared to traditional surgical approaches in prostate cancer management. These findings reinforce its role as a powerful, patient-centric alternative in modern urology.
Redefining the Future of Focal Therapy
Focal One Robotic HIFU represents a major leap forward in minimally invasive prostate treatment. By combining robotics, intelligent imaging, advanced software, and automated safety features, it delivers a level of precision and personalization previously unattainable.
For wellness-focused healthcare providers and patients seeking advanced, tissue-sparing solutions, Focal One stands at the forefront of the future of focal therapy.