FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Clears SpineGuard’s DSG Integration Module to Market

Jan. 18, 2017
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SpineGuard has received FDA marketing clearance for its DSG (Dynamic Surgical Guidance) integration module for use in combination with Zavation’s spinal fusion system.

A DSG-enabled screw is a combination of a bipolar sensor and a pedicle screw in one device. The technology offers surgeons real-time guidance and the ability to insert the screw directly into a vertebra without drilling a pilot hole.

The DSG sensor differentiates various tissue types based on the analysis of the local electrical conductivity. Real-time feedback informs the surgeon of changes in tissue type by an audio signal varying in pitch and cadence. This alerts surgeons to potential breaches during screw placement and allows them to redirect the screws. — Cynthia Jessup

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