Epitel Receives FDA 510(k) Clearance for Two New Technologies: REMI Remote EEG Monitoring System for Ambulatory Use and REMI Vigilenz AI For Event Detection [Yahoo! Finance]
DexCom, Inc. (DXCM)
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Source: Yahoo! Finance
SALT LAKE CITY, April 23, 2024 BUSINESS WIRE Epitel , a leader in AI technologies for patient-focused brain health solutions, announced today it received U.S. Food and Drug Administration (FDA) 510(k) clearances for two new innovative technologies: REMI™ Remote EEG Monitoring System for Ambulatory (at home) use and REMI Vigilenz™ AI For Event Detection. REMI for Ambulatory use allows EEG recording in outpatient and home environments for an extended duration, while REMI Vigilenz AI for Event Detection analyzes and marks REMI EEG records for potential electrographic seizures to assist with ease and accuracy of interpretation. "Existing EEG monitoring systems have been cumbersome and restrictive for patients, and technical requirements and limitations have impeded providers' ability to administer, record, and interpret EEG. REMI Ambulatory and REMI Vigilenz AI For Event Detection will help patients and providers make better-informed treatment decisions," said Mark Lehmkuhle, PhD, Chie
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