INTENDED FOR U.S. AUDIENCES ONLY
EPITEL™: REVOLUTIONIZING
HOW BRAIN HEALTH IS MONITORED
Epitel is a digital health company modernizing brain health solutions to improve seizure monitoring and detection. By leveraging our proprietary cloud-based wearable sensor system and other innovative AI technologies, we are empowering better treatment decisions by making EEG readily deployable and accessible. We are headquartered in Salt Lake City.
We’ve developed a wearable, wireless EEG monitoring platform to provide accessible, affordable, and reliable electrographic seizure detection. Epitel received FDA clearance for its first product, known as REMI™ Remote EEG Monitoring System, in 2021.
MEET OUR TEAM
We are a diversely talented team with expertise in medical devices, big data analytics, and computational neuroscience.
Neural Engineer, entrepreneur,
25+ years neural engineering, epilepsy, and signal processing
MARK LEHMKUHLE, PhD
CEO/CTO, Founder
MATT PARROTT
VP of Manufacturing
25+ years in global product development, engineering, and manufacturing for medical hardware
CHRIS PHILLIPS
VP of Regulatory & Quality
20+ years in medical device regulatory, quality, and clinical affairs
MITCH FRANKEL, PhD
Senior Computational Scientist
15+ years in neural and biorobotic engineering as well as biomedical device development and testing
ROB LINGSTUYL
Software Architect
20+ years in multiplatform software application development
JACKIE DORSKY
VP of Marketing
15+ years in healthcare marketing, leading dynamic teams and medical device launches
JAMES LANDIS
VP of Sales and Commercialization
18+ years in healthcare sales, specializing in the commercialization
of innovative products
MARK FORAN
Senior Director
of Medical Affairs
18+ years in medical affairs and healthcare leadership
MICHAEL ELWOOD
Electrical Engineer
25+ years developing medical devices
REMI SYSTEM SAFETY INFORMATION
INDICATIONS
REMI Remote EEG Monitoring System Indications for Use
The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI uses single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days.
The REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-shelf mobile computing platforms. REMI Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software.
REMI does not make any diagnostic conclusion about the subject’s condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).
Please click here for full Instructions for Use for REMI™ Healthcare Facility and REMI™ Ambulatory.
REMI Vigilenz AI For Event Detection Indications for Use
REMI Vigilenz AI For Event Detection is indicated for the analysis of REMI Remote EEG Monitoring System electroencephalogram (EEG) recordings. REMI Vigilenz AI For Event Detection is intended to be used by physicians qualified to analyze and interpret EEG who will exercise professional judgment in using the information.
As an aide to the qualified physician’s REMI EEG review, REMI Vigilenz AI For Event Detection marks previously acquired sections of REMI EEG that may correspond to neurological events of interest indicative of potential electrographic seizures lasting at least 10 seconds in duration. REMI Vigilenz AI For Event Detection is indicated for use with adult and pediatric patients (6+ years).
REMI Vigilenz AI For Event Detection does not mark REMI EEG records in real time and does not provide any diagnostic conclusion about the patient’s condition to the user.
Please click here for full Instructions for Use for REMI Vigilenz™ AI for Event Detection.
465 S. 400 E
Suite 250
Salt Lake City, UT 84111
801-497-6297
info@epitel.com
Instructions for Use for REMI™ Healthcare Facility, REMI™ Ambulatory, and REMI Vigilenz™ AI for Event Detection.
© 2024 BY EPITEL
All rights reserved. Epitel, REMI, and REMI Vigilenz AI are trademarks of Epitel, Inc.
All other trademarks are the property of their respective owners.
For technical and customer support, please call:
801-497-6297