Michael Barbella, Managing Editor06.01.23
EDAP TMS SA has received approval from the Pharmaceutical and Medical Devices Agency (PMDA) to commercialize the ExactVu micro-ultrasound biopsy platform in Japan.
“We are pleased to announce the approval of the ExactVu system in Japan,” EDAP TMS CEO/Board Chairman Marc Oczachowski said. “The Japanese market is the second largest market for advanced medical device technology in the world, and prostate cancer is the most common cancer diagnosis in Japanese men. Each year, there are over 100,000 newly diagnosed cases of prostate cancer. Our established commercial team in Japan is well positioned to engage clinical sites to offer their patients precise prostate biopsies utilizing this groundbreaking technology.”
ExactVu is a micro-ultrasound platform that provides the most practical solution as a new tool for urologists or radiologists to perform targeted biopsies within a standard urological workflow. The 29MHz frequency allows practitioners to visualize details unseen before in any prostate ultrasound image, detect suspicious areas in real-time and take a biopsy sample as representative of the level of aggressiveness of the cancer. ExactVu is already available for sale in the European Union, the United States, and Canada.
EDAP TMS develops, manufactures, promotes, and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One in Europe and in the United States as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of prostate cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith i-move lithotripter and lasers for treating urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).
“We are pleased to announce the approval of the ExactVu system in Japan,” EDAP TMS CEO/Board Chairman Marc Oczachowski said. “The Japanese market is the second largest market for advanced medical device technology in the world, and prostate cancer is the most common cancer diagnosis in Japanese men. Each year, there are over 100,000 newly diagnosed cases of prostate cancer. Our established commercial team in Japan is well positioned to engage clinical sites to offer their patients precise prostate biopsies utilizing this groundbreaking technology.”
ExactVu is a micro-ultrasound platform that provides the most practical solution as a new tool for urologists or radiologists to perform targeted biopsies within a standard urological workflow. The 29MHz frequency allows practitioners to visualize details unseen before in any prostate ultrasound image, detect suspicious areas in real-time and take a biopsy sample as representative of the level of aggressiveness of the cancer. ExactVu is already available for sale in the European Union, the United States, and Canada.
EDAP TMS develops, manufactures, promotes, and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One in Europe and in the United States as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of prostate cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith i-move lithotripter and lasers for treating urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).