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Medical Devices / Submissions and Approvals

7D Surgical’s Cranial Module Device Receives FDA Approval

Aug. 14, 2018

The FDA granted 510(k) clearance for 7D Surgical’s machine-vision image guided surgery (MvIGS) system for use in cranial surgery.

The device uses machine vision algorithms and camera-based tech to acquire virtual fiducial markers from the patient’s anatomy, allowing for cranial registration in nearly any surgical position.

It can also register multiple datasets to visualize the patient’s anatomy using many types of medical imaging.

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