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Medical Devices / Submissions and Approvals

FDA Clears Elucent’s Surgical Navigation System

April 12, 2019
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The FDA granted 510(k) clearance for Elucent Medical’s EnVisio surgical navigation system, a device that helps breast surgeons to pinpoint malignancies.

In conjunction with the company’s implantable SmartClip soft tissue marker, the device can to identify malignancies and wirelessly navigate to them in real-time.

The system allows physicians to mark difficult-to-access lesions and removes the need for hook-wire implantation in the breast, the standard approach to identifying tissue for removal.

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