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ANT Neuro announces 510(k) clearance for visor2™ TMS Neuronavigation System

ANT Neuro announces 510(k) clearance for visor2™ TMS Neuronavigation System

ANT Neuro proudly announces that the visor2™ TMS Neuronavigation System has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA). The visor2™ system provides a neuronavigation solution for the most advanced and accurate clinical treatment with noninvasive transcranial magnetic stimulation (TMS).

“We are excited to introduce the visor2™ system to the U.S. clinical TMS market," said Frank Zanow PhD, CEO and founder of ANT Neuro. “With this clearance, not only US practitioners will now be able to benefit from the many advantages of neuronavigation for TMS and the unique capabilities of visor2™, but also patients will profit from more personalized and effective navigated TMS treatments.”

With its intuitive step-by-step workflows, the visor2™ system guides users through the entire navigated TMS treatment session; from the patient data management to precise and reproducible navigation of the TMS coil throughout multiple treatment sessions. To facilitate more personalized TMS, the patient’s MRI data can be used for MRI-assisted neuronavigation. Alternatively, in clinical settings where patient specific MRI data is not available, a simple and precise MRI-less and scalp-based navigation for TMS coil targeting can be used. The TMS stimulation location and individual motor threshold level required for optimal therapy can be determined with integrated recording of electromyography (EMG).

KC Chelette, CEO of ANT Neuro North America adds: “visor2™ is the only FDA 510(k) cleared TMS neuronavigation system available in the US that supports FDA 510(k) cleared TMS coils and stimulators from all major TMS manufacturers, including: Magstim, MagVenture, Mag&More and Neuronetics. The visor2™ system provides a cost-effective solution for easily integrating neuronavigation into existing TMS treatment setups!”

visor2™ is available to order and ship to U.S. clinicians. It will be featured at the ANT Neuro booth at leading U.S. trade shows and workshops throughout the year, including the 10th Annual Meeting of the Clinical TMS Society in Chicago, Illinois, from May 12 - 14, 2022.

The visor2™ system is manufactured by eemagine Medical Imaging Solutions GmbH who is a leading manufacturer and developer of medical devices, software and services for research and clinical markets, including clinical neuroscience, newborn care, and neurology. eemagine’s products are marketed under the ANT Neuro brand and are sold into hospitals, clinics, and research facilities world-wide.

For more information about visor2™, please visit the visor2™ product page or contact us here.

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