Soterix Medical Announces FDA 510(k) Clearance of MEGA-IOM Intraoperative Neuromonitoring System

WOODBRIDGE, N.J., July 24, 2024 /PRNewswire/ -- Soterix Medical Inc., the global leader in stimulation and synergistic monitoring technologies, announced today it has received a 510(k) clearance from the U.S. Food & Drug Administration for its Intraoperative Neurophysiologic Monitoring (IOM) system, MEGA-IOM. The system provides unmatched integrated control of central and peripheral nervous systems to reduce postoperative risk and improve surgical outcomes. ­It includes preset modalities such as motor evoked potentials (MEP) to evaluate the integrity of motor pathways, somatosensory evoked potentials (SSEP) to evaluate the integrity of sensory pathways and detect brain and spinal cord ischemia, EEG to record and analyze brain activity (functional state of the brain), and direct stimulation to control the functional integrity of peripheral nerves.

"This FDA authorization represents a significant milestone for our organization as we can now offer the MEGA-IOM system to surgical teams across the U.S.," said Ms. Danielle Dadona, VP of Regulatory Affairs of Soterix Medical. "This U.S. manufactured system pairs with an intuitive, rich, software interface with exceptional usability."

Mr. Kamran Nazim, Chief Product Officer of Soterix Medical commented "MEGA-IOM is a cutting-edge modular platform solution that combines years of knowledge and experience obtained in clinical and research environments. Due to flexible channel configuration and size options (cart-based or portable), the system can meet the most exacting needs of both surgeons and advanced neuromonitoring specialists."

Surgeons, neurophysiologists, neurologists and intraoperative monitoring service companies in the United States interested in incorporating the MEGA-IOM system are eligible for Soterix Medical's Partnership program which includes support on the entire system, hands-on training and staff certification. Interested parties should contact Soterix Medical (at [email protected]) for additional information.

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SOURCE Soterix Medical, Inc.