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Soterix Medical Announces FDA 510(k) Clearance for the MEGA-TMS System

New York City – Aug 30, 2021

Soterix Medical Inc., the global leader in non-invasive stimulation and synergistic technologies, announced today it has received a 510(k) clearance from the U.S. Food & Drug Administration for its monophasic Transcranial Magnetic Stimulation device, the MEGA-TMS system. The system is intended for the stimulation of peripheral nerves for diagnostic purposes.

Ms. Claudia Giselle, Soterix Medical’s VP Regulatory Affairs, explains “This FDA authorization represents yet another milestone for our organization. In combination with the previously cleared Electromyography (EMG) solution, users can now evaluate the integrity of spinal roots and peripheral nerves in a wide range of diseases. Additionally, this authorization clears all components needed individually for performing functional localization with motor mapping.

Mr. Kamran Nazim, Chief Product Officer of Soterix Medical adds, "The clearance of MEGA-TMS reflects Soterix Medical’s commitment to continue to commercialize highly innovative non-invasive neuromodulation technologies for wider clinical use. The MEGA-TMS incorporates the highest maximum voltage rated capacitor in its class allowing generation of higher power single-pulse stimuli. With a big bright 7-inch LCD screen and a highly intuitive interface leveraging our renowned expertise in usability engineering, the system is already a step ahead of other magnetic stimulation devices.”

Soterix Medical already holds FDA clearance for Neuronavigation that is intended for the accurate positioning of treatment coil during repetitive Transcranial Magnetic Stimulation treatment for Major Depression. This latest FDA clearance provides Soterix Medical with among the widest portfolio of magnetic stimulation technologies spanning a range of diagnosis and therapeutic indications. The portfolio complements Soterix Medical offering of electrical neuromodulation and brain imaging products providing clinicians and researchers unparalleled brain modulation / imaging system integration.

Neurologists and Neurosurgeons in the United States interested in incorporating the MEGA-TMS system are eligible for Soterix Medical's Partnership program which includes support on the entire patient set-up pipeline, hands-on training and staff certification, data quality inspection, and connection to our network of physicians. Interested parties should contact Soterix Medical (at contact@soterixmedical.com) for additional information.

Media Contact: Mariana Shuster
Tel: +1-888-990-8327
Email: contact@soterixmedical.com

At Soterix Medical Inc., Engineering Serving Humanity means that we're committed to bring the most advanced medical technology into the hands of people who need it. The commitment underpins everything we do.

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