SALT LAKE CITY—Epitel, Inc. announced that its REMI Neuro Monitoring Home Health Hub has been selected by the U.S. Food and Drug Administration (FDA) to participate in a home innovation challenge. Epitel said it is one of the first two companies selected to advance to the program’s interaction phase.
Launched as part of the FDA Center for Devices and Radiological Health's Home as a Health Care Hub Initiative, the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge invites innovators to propose medical devices that support patients and caregivers in the home setting following an acute hospital stay. The interaction phase provides 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 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%.
Epitel’s REMI Neuro Monitoring Home Health Hub is a 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. The company said 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, chief technology officer 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.”