Soterix Medical Receives FDA Clearance for Advanced Intraoperative Monitoring System

Soterix Medical Inc., a leader in stimulation and monitoring technologies, announced that its Intraoperative Neurophysiologic Monitoring (IOM) system, MEGA-IOM, has received 510(k) clearance from the U.S. Food & Drug Administration. The MEGA-IOM system offers comprehensive control over central and peripheral nervous systems to enhance surgical outcomes and reduce postoperative risks. It features preset modalities such as motor evoked potentials, somatosensory evoked potentials, EEG, and direct stimulation to ensure the functional integrity of motor and sensory pathways during surgeries.

Ms. Danielle Dadona, VP of Regulatory Affairs at Soterix Medical, expressed the significance of this FDA authorization, emphasizing that the MEGA-IOM system can now be made available to surgical teams across the U.S. The system boasts a user-friendly software interface and superior usability, aligning with the company's commitment to providing top-tier neuromonitoring solutions. Chief Product Officer Mr. Kamran Nazim highlighted the system's modular platform, which draws from extensive clinical and research experience, and offers flexible configurations to meet the needs of both surgeons and advanced neuromonitoring specialists.

The MEGA-IOM system is now accessible to surgeons, neurophysiologists, neurologists, and intraoperative monitoring service companies in the United States through Soterix Medical's Partnership program. This program includes comprehensive support, hands-on training, and staff certification, ensuring seamless integration and optimal use of the advanced monitoring technology.

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