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Neural Navigator FDA cleared!
Brain Science Tools BV is proud to announce that our Neural Navigator, marketed in the USA by our partner Soterix Medical, received FDA clearance today as a class II medical device per April 6th. This will allow Soterix Medical to offer our innovation to clinical users in the USA.
The Neural Navigator is an accurate MRI guidance system that augments TMS therapy.
From our 510k summary:
“The Neural Navigator is a neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft.
The Neural Navigator combines MRI-based, 3-D localization of cortical motor areas of the brain with non-invasive TMS and simultaneous EMG measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy. It uses reliable and accurate electromagnetic position tracking of TMS coils and the head of the patient.
The Neural Navigator software is used to import a patient’s MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient’s head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.”
We are very happy to be able to bring our innovations to patients and doctors in the USA, and augment TMS therapy for depression. We will continue innovate TMS therapy and navigated motor mapping and bring our innovative products to the clinic as soon as possible. Are you interested to obtain a quote for the Neural Navigator in the USA, please go to the Soterix website , or to our website or one of our worldwide distributors when you are based outside the USA.
We are looking forward to speaking to you in the coming days!