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nëo receives FDA 510(k) clearance

nëo receives FDA 510(k) clearance

BERLIN, Germany, February 27, 2020 – eemagine Medical Imaging Solutions GmbH and ANT Neuro announced today that the nëo™ Monitor System has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA). The nëo™ Monitor System is a neonatal aEEG/EEG device that acquires, displays, stores, and archives electroencephalographic signals from the brain. The system is compact, easy to use, and designed for use by qualified clinicians in the Neonatal Intensive Care Unit (NICU).

"We are excited to bring the new nëo™ Monitor System to the U.S. market," said Frank Zanow PhD, CEO and founder of eemagine Medical Imaging Solutions GmbH and ANT Neuro. “The nëo™ Monitor System strengthens our portfolio of clinical EEG products and ensures that clinicians and their patients can benefit from the latest advancements in neonatal bedside brain monitoring."

Built on eemagine Medical Imaging Solutions GmbH and ANT Neuro’s 20-year expertise of high-quality research and clinical solutions, the nëo™ Monitor System brings reliability, performance, and exceptional value to U.S. NICU clinicians. It features indicators designed to aid in the visual assessment of the aEEG and underlying EEG, including an option for the greyscale display of the aEEG, and easy to interpret numeric values of brain status (inter-burst interval and burst suppression ratio). In addition, electrode management is simplified with the high impedance input of the research grade eego™ amplifier, providing high data quality with minimized artifacts through the nëo™ Monitor System’s active shielding technology.

Designed with input from neonatologists and neurologists, the nëo™ Monitor System improves access to important brain function data and simplifies the workflow in the busy NICU setting through ease of setup, intuitive navigation, and customizability of the monitoring settings.

The nëo™ Monitor System will soon be available to order and ship to U.S. customers. It will be featured at the ANT Neuro booth at leading U.S. trade shows and workshops throughout the year.

eemagine Medical Imaging Solutions GmbH is a leading manufacturer and developer of medical devices, software and services for various research and clinical markets, including Newborn Care and Neurology. The products are marketed under the ANT Neuro brand and are sold into hospitals, clinics and research facilities world-wide.

Please visit www.ant-neuro.com/products/neo for more information about the nëo™ Monitor System.

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