The French company’s Focal One device uses both magnetic resonance and 3D biopsy data, alongside real-time ultrasound imaging, to allow urologists to view 3D images of the prostate while using high intensity ultrasound to ablate the tissue.
“Focal One is a great step forward in using this new and important ultrasound technology for prostate tissue ablation. Focal One’s ability to merge MRI images, ultrasound images and biopsy data in order to precisely outline and treat just the diseased tissue area of the prostate is truly remarkable,” Urologist Dr. Brian Miles of Houston Methodist Hospital said in a prepared statement.
Edap touted that its Focal One system allows for more precise targeting and smaller portions of the prostate ablated, which it says minimizes side effects of incontinence and impotence.
“We are thrilled that this innovative technology will now be available to patients and physicians in the United States. The FDA’s clearance of Focal One validates not only the power of our technology but also the years of hard work and dedication by our clinical trial investigators and Edap’s outstanding employees. Focal One’s real-time imaging and 3D robotic features allow for greater precision, leading to improved targeting and treatment planning, and we are excited to be able to expand access to Focal One to the most important healthcare market in the world,” EDAP CEO Marc Oczachowski said in a press release.