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# FDA Clears Medtronic StealthStation Cranial Software
- URL: https://www.fdaweb.com/fda-clears-medtronic-stealthstation-cranial-software/
- Published: 2016-09-27T12:00:00.000Z
- Updated: 2026-09-14T21:35:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136922

FDA has cleared a Medtronic 510(k) for the StealthStation cranial software as an aid for deep brain stimulation (DBS) lead placement. The software is fully integrated with the company’s latest O-arm Imaging System that helps clinicians with the planning and placement of DBS leads. With Medtronic's DBS Therapy, a small, pacemaker-like neurostimulator is implanted under the skin of the chest and sends electronic signals to an area in the brain that controls movement. Medtronic says thin wire leads are implanted in the brain and are connected to the neurostimulator by an extension to enable the signals to reach the symptom source.