Epitel, Inc. today announced that its REMI™ Neuro Monitoring Home Health Hub has been selected by the U.S. Food and Drug Administration (FDA) to participate in the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge. Epitel is one of the first two companies selected to advance to the program’s interaction phase.
About the FDA READI-Home Innovation Challenge: Launched as part of the FDA Center for Devices and Radiological Health’s (CDRH) Home as a Health Care Hub Initiative, the FDA program invites innovators to propose medical devices that support patients and caregivers in the home setting following an acute hospital stay. The interaction phase provides valuable early engagement with the FDA, allowing for rapid feedback to help refine device design and testing for home-use indications. READI aims to accelerate patient access to medical device technologies that can successfully reduce avoidable hospital readmissions. Hospital readmissions create significant logistical, financial, and personal challenges, with 30-day readmission rates for people with chronic conditions reaching up to 18.4%.
For more information about the READI-Home program and the official list of initial participants, please visit the FDA’s website: FDA READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home.
Advancing Neurological Care at Home with REMI: Epitel’s REMI™ Neuro Monitoring Home Health Hub is an innovative, wireless wearable electroencephalography (EEG) system designed for extended-duration monitoring. Applied at the point of discharge from the hospital, the REMI system is intended for use in home and ambulatory environments by individuals six years of age and older.
Epitel currently offers the wireless and wearable REMI Remote EEG Monitoring System and REMI Vigilenz™ AI for Event Detection, which together help clinicians gather EEG and assess patients for potential seizures. The REMI Neuro Monitoring Home Health Hub expands upon these technologies to create a monitoring solution for use after or instead of a hospital stay, assessing patients for potential seizures, poor sleep, and delirium. By empowering continuous, reliable neurological monitoring outside of a traditional clinical setting, REMI aims to deliver critical insights to healthcare providers, facilitating timely interventions and significantly reducing the likelihood of a hospital readmission.
“We are incredibly honored that the FDA has selected REMI as one of the inaugural technologies for the READI-Home Innovation Challenge,” said Mark Lehmkuhle, CTO at Epitel. “Our mission has always been to make brain health monitoring more accessible and comfortable. Working directly with the FDA allows us to rapidly adapt neuro-monitoring for home environments, helping support post-discharge patients and easing pressure on overloaded health systems.”
About Epitel:
Epitel® is a digital health company modernizing brain health solutions to improve patient care. By leveraging a proprietary cloud-based wearable sensor system and innovative AI technologies, Epitel empowers better treatment decisions by making EEG readily deployable and accessible. Headquartered in Salt Lake City, Epitel is dedicated to advancing neurological care across diverse healthcare settings. Visit www.epitel.com to learn more.
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