PLYMOUTH, Minn., May 3, 2021 /PRNewswire/  Surgical Information Sciences (SIS), a medical device company focused on improved targeting for deep brain stimulation (DBS) surgery, announced the first use of the SIS System which recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The SIS System uses deep learning models to identify brain structures such as the subthalamic nuclei (STN) and globus pallidus internus/externus (GPi/GPe) commonly targeted for DBS procedures. The SIS System provides visualization of these structures for surgical planning and for location of the implanted DBS leads and lead contacts post-surgery.
The STN and GPi/GPe are key targets for patients with Parkinson s disease. The advancement of DBS has provided a potentially profound solution to patients with Parkinson s disease; however, it is still significantly underutilized due to a lack of consistent results and challenges with the procedure. Â Despite advances in imagi
Surgical Information Sciences Announces FDA 510(k) Clearance for Additional Anatomical Structures for its DBS Visualization Software
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MINNEAPOLIS, April 5, 2021 /PRNewswire/ Surgical Information Sciences (SIS), a medical device company focused on improved targeting for deep brain stimulation (DBS) surgery, announced it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market an updated algorithm with new visualization capabilities. Prior to this, the SIS System was cleared for visualization of brain structures such as the subthalamic nuclei (STN) in the planning and targeting images for a DBS procedure and visualization of the location of the STN relative to the implanted DBS leads, including identification of the lead contacts.
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