ExactVu micro-ultrasound system receives 510(k) clearance in US- Exact Imaging
Exact Imaging has received FDA 510(k) Clearance for its ExactVu micro-ultrasound system. The ExactVu micro-ultrasound recently received CE marking enabling sales of the system in Europe. Exact Imaging's European commercial operations are being set-up in its new European headquarters in Belgium. With this 510(k) clearance, North American sales, clinical applications and technical support teams are being expanded to support the anticipated growth in US customers.
Comment: With resolution down to 70 microns, the ExactVu high resolution system provides a 300% improvement in imaging resolution compared to the traditional standard-of-care urological ultrasound systems.
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