CareFusion released its Nicolet EEG (electroencephalography) Wireless Amplifier this week, a device that captures high-resolution brain wave data and transmits it wirelessly to a monitoring computer. The device received FDA 510(K) clearance this past April.
The Nicolet (pronounced "nick-oh-lay") EEG Wireless Amplifier is a portable unit, intended for hospitals, clinics, emergency vehicles and in-home ambulatory settings, which aids in the diagnosis and treatment of epilepsy, brain trauma, stroke, brain tumors, sleep dysfunction and clinical research. Data from the device can be transmitted wirelessly, in real-time, to a monitoring computer, or stored in the device's memory -- if a monitoring computer isn't nearby -- for later upload.
Last summer, CareFusion joined the West Wireless Health Institute (WWHI) as a Technology and Education (T&E) partner (along with Cisco and Medtronic). The TE partners work closely with the Institute’s clinical and engineering teams on a variety of research, technology and educational initiatives focused on accelerating wireless health solutions.
While CareFusion didn't mention an app component to its EEG system, mobile apps that display previously stored EEG waveforms are one of the types of medical apps included in the FDA proposed guidelines for mobile medical app regulation, according to its draft guidance released this summer.
"Wireless acquisition of EEG data gives patients admitted to the epilepsy monitoring unit greater freedom and comfort without risking loss of critical data due to disconnection of the amplifier," stated Chad Carlson, M.D., assistant professor of neurology at the New York University Langone Medical Center Comprehensive Epilepsy Center, in a press release. "The ability to record up to 64 channels of EEG data at up to 12 kHz should allow for further advances in clinical EEG analysis and interpretation."
See a product video of the EEG below:
Want to read stories as soon as they are posted? Follow MobiHealthNews on Facebook.
On Twitter? Be sure to follow MobiHealthNews for up-to-the-minute news and industry analysis.
Read the press release below.
PRESS RELEASE -- CareFusion today launched the Nicolet™ EEG (Electroencephalography) Wireless Amplifier, a device that effectively captures high-resolution brain wave data used for the diagnosis and treatment of neurological diseases and conditions.
The Nicolet EEG Wireless Amplifier consolidates many clinical and research features into a single, portable unit for pediatrics and adults to aid clinicians in their diagnosis and treatment of epilepsy, brain trauma, stroke, brain tumors, sleep dysfunction and clinical research. Real-time data from the amplifier can be transferred wirelessly or in tethered mode and stored in the product's on-board memory allowing for continuous recording when patients are out of range of a monitoring computer. This device is ideally suited for hospitals, clinics, emergency vehicles and in-home ambulatory settings.
With the addition of the EEG Wireless Amplifier, along with a series of traditional Nicolet EEG and Electromyography (EMG) systems, CareFusion now offers customers a comprehensive neurodiagnostic monitoring product line that provides high quality, rich data to clinicians to help them more effectively deliver patient care."Wireless acquisition of EEG data gives patients admitted to the epilepsy monitoring unit greater freedom and comfort without risking loss of critical data due to disconnection of the amplifier," said Chad Carlson, M.D., assistant professor of neurology at the New York University Langone Medical Center Comprehensive Epilepsy Center. "The ability to record up to 64 channels of EEG data at up to 12 kHz should allow for further advances in clinical EEG analysis and interpretation."
Mary de Sousa, vice president and general manager of NeuroCare at CareFusion, said: "With the introduction of the new wireless amplifier, hospitals and clinics have a new standard of care available to them for diagnosing, monitoring and helping them treat patients with neurological disorders."
The Nicolet EEG Wireless Amplifier is available worldwide. CareFusion will demonstrate the wireless amplifier, along with other Nicolet product lines, at the 2011 American Epilepsy Society meeting held Dec. 3 – 7 in Baltimore. Visit Nicolet-CareFusion at booth #213.
About CareFusion
CareFusion (NYSE: CFN) is a global corporation serving the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops market-leading technologies including Alaris® infusion pumps, Pyxis® automated dispensing and patient identification systems, AVEA®, AirLife™ and LTV® series ventilation and respiratory products, ChloraPrep® skin prep products, MedMined™ services for data mining surveillance, Nicolet™ neurological monitoring and diagnostic products, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine. CareFusion employs more than 14,000 people across its global operations. More information may be found at www.carefusion.com and www.carefusion.com/eegwireless.