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).