Elucent Medical gets FDA OK for surgery navigation device

Medical equipment manufacturer Elucent Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its EnVisio surgical navigation device.

EnVisio is designed to help surgeons identify the location of breast cancers with real-time 3D navigation. The device works in conjunction with Elucent's implantable wireless SmartClip soft-tissue markers to allow surgeons to mark lesions as well as determine distances between lesions and surrounding structures.

The technology offers a cost-effective alternative to standard breast cancer localization techniques that often involve inserting a hook wire in the breast, Elucent Medical said.

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