This illustration depicts the Focal One Robotic HIFU system’s dynamic focusing probe imaging a patient’s prostate from inside their rectum. [Image courtesy of EDAP Technomed]
The team used the robotic Focal One high-intensity focused ultrasound (HIFU) system to deliver focal therapy for ablation of non-metastatic prostate tumors.
“Focal therapy involves using a robotic arm to deliver ultrasound waves to the prostate to treat prostate cancer,” Cleveland Clinic Abu Dhabi Department Chair of Urology Dr. Waleed Hassen said in a video posted to LinkedIn. “In this case, while I was at the bedside with the patient in Abu Dhabi, I was able to transfer controls of the robotic arm to my colleague in Cleveland. … He was enabled to seamlessly perform the procedure from beginning to end without my intervention. It was as if he was in the room sitting next to me.”
EDAP Technomed’s Focal One Robotic HIFU system [Image courtesy of EDAP Technomed]
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The prostate tumor ablation procedure — which requires no major surgery or radiation exposure — took about an hour and was completed without any complications, Cleveland Clinic said.
It’s the latest advance in telesurgery as medical device developers and researchers combine robotics, device connectivity and advanced imaging to make life-saving technologies available across the globe — and beyond.
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The Focal One Robotic HIFU system is a minimally invasive approach to treating prostate cancer. [Image courtesy of EDAP Technomed]
Olivares is scheduled to discuss the remote procedure on April 28 at the American Urological Association (AUA) annual meeting in Las Vegas.
The Focal One Robotic HIFU system
Austin, Texas-based EDAP Technomed (the U.S. subsidiary of France-based EDAP TMS) won FDA clearance in 2018 for prostate tissue ablation with its Focal One device, but the company said the remote technology used in this first-of-its-kind procedure is not yet available for sale.
The goal of this first procedure was to successfully demonstrate feasibility and gain valuable insights, the company said in a statement shared with Medical Design & Outsourcing. “The next step is to conduct additional procedures with the Cleveland Clinic teams to gather additional clinical feedback and finalize the technical requirements for commercialization.”
The Focal One robotic automatic positioning system has five degrees of freedom and submillimetric accuracy for precise targeting of prostate tumors while protecting the patient’s rectal wall. [Image courtesy of EDAP Technomed]
“HIFU technology directs high-intensity sound waves through an ultrasound probe to a precisely controlled focal point within the prostate,” EDAP explains at its website. “This rapid concentration of energy increases the temperature at the targeted area, causing coagulation necrosis that destroys cancerous cells while sparing the surrounding healthy tissue. This precision minimizes damage to critical surrounding structures, significantly reducing side effects.”
Ultrasound imaging frequency is typically in the 3-10 MHz range around 0.02 W, while the Focal One HIFU therapy uses focused ultrasound beams at 3 MHz at 200 W.
The Focal One robotic automatic positioning system has five degrees of freedom and submillimetric accuracy for precise targeting of the tumor in 5 mm increments (up to 40 mm) while protecting the patient’s rectal wall.
“Robotic execution of planned ablation is performed with unparalleled accuracy, ensuring safe and effective outcomes,” the company says.
This illustration depicts the Focal One Robotic HIFU system’s probe ablating a prostate tumor with ultrasound energy. [Image courtesy of EDAP Technomed]
Its proprietary HIFUsion software allows the physician to overlay “MRI and/or 3D biopsy data for precise contouring,” the company says.
“Focal One integrates pre-operative MRI and 3D biopsy data with real-time ultrasound to provide accurate precision,” the company continued. “This allows the urologist to contour precisely to target the lesion and avoid critical structures. HIFUsion is an open-platform concept that uses the latest DICOM standard compatible with all MRI scanners and most fusion biopsy platforms.
Safety features include a rectal cooling system with real-time monitoring and control of the company’s patented Ablasonic cooling liquid. The system also monitors the rectal wall position in real time with ultrasound image to automatically adjust the probe with the robot, and can also detect patient movement to automatically halt the ablation.
“Unlike other focal therapy treatment technologies requiring surgeons to manually position needles based on 2D visual feedback, Focal One’s design allows the treatment to be controlled through a fully digital 3D interface,” the company said in its statement. “The personalized treatment plan is developed by the surgeon using an intuitive on-screen interface, while the fully robotic positioning system ensures precise delivery of HIFU energy driven by the surgeon-defined treatment plan. This sophisticated design allowed the development of a Focal One remote workstation that mirrors the dual treatment screens on the Focal One system and provides real-time communications between the Focal One remote workstation and the Focal One system. This achievement demonstrates that the Focal One system is ideally suited for this type of telecollaboration.”
The potential applications go beyond prostate cancer. In March 2024, the FDA gave the Focal One HIFU system a Breakthrough Device Designation for treating deep-infiltrating endometriosis.
“Receiving Breakthrough Device designation from the FDA represents a major milestone and reinforces our commitment to expand the use of Focal One Robotic HIFU technology to treat other patient conditions beyond prostate disease,” EDAP Technomed CEO Ryan Rhodes said at the time.
In March 2025, the company secured a CE mark for treating posterior deep endometriosis infiltrating the rectum and surrounding structures. The company is also evaluating the technology for treating benign prostatic hyperplasia and conducting clinical research on the treatment of tumors in organs such as the pancreas.
EDAP had 130 active Focal One systems placed as of the end of 2024, including 65 in the U.S., the company said in its most recent annual report.
“The majority of academic centers using the Focal One system are collecting data following an Investigational Review Board approval in order to continue building clinical evidence and long-term HIFU outcomes,” the company said. “These various sources of clinical data are a basis for individual sites to present abstracts at regional, national or international conferences and submit manuscripts for peer-review to renowned journals and publications. This holds the potential for the FDA, which cleared HIFU for prostate tissue ablation in 2015, to re-evaluate the technology in the future for prostate cancer indication.”
