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.
MEGA-IOM provides unmatched integrated
control of central and peripheral nervous systems to reduce
postoperative risk.
"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 contact@soterixmedical.com) for additional information.
Media Contact: Chaya
Edelman
Tel: +1-888-990-8327
Email: contact@soterixmedical.com
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SOURCE Soterix Medical, Inc.