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www.fdanews.com/articles/177871-medtronic-gets-ce-mark-for-software-used-in-dbs-therapy-devices

Medtronic Gets CE Mark for Software Used in DBS Therapy Devices

August 8, 2016

Ireland-based Medtronic received CE Mark approval for its SureTune2 software for use in deep brain therapy devices.

The software allows for patient-specific visualization during DBS therapy. The therapy device emits mild electrical stimulation to targets in the brain in order to modulate specific symptom control.

SureTune2 is currently not approved in the United States. — Cynthia Jessup

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