EDAP TMS SA provided a regulatory and clinical update. The Company has received approval from the Pharmaceutical and Medical Devices Agency PMDA for the commercialization of the ExactVu micro-ultrasound biopsy platform in Japan. 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 unique 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 (CE Mark), the United States (FDA 510(k) clearance), and in Canada (Health Canada license).