COMPANY
Epitel
Timeline
- FDA FDA 510(k) clearance: REMI Remote EEG Monitoring System — K243185, Mar 21, 2025. Applicant at approval: Epitel. source ↗
- FDA FDA 510(k) clearance: REMI-AI Rapid Detection Module (REMI-AI RDM) — K240408, Oct 17, 2024. Applicant at approval: Epitel, Inc. source ↗
- Trial start Not phased (device or behavioral study): Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System. source ↗
- Trial start Not phased (device or behavioral study): Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units source ↗
- Trial start Not phased (device or behavioral study): A Wireless EEG Patch for Continuous Electrographic Monitoring source ↗
Clinical trials (lead sponsor) 3
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06027749 | Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System. | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Oct 13, 2023 | Mar 30, 2025 (estimated) |
| NCT03583957 | A Wireless EEG Patch for Continuous Electrographic Monitoring | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | May 8, 2018 | Apr 30, 2026 (estimated) |
| NCT05818930 | Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Mar 8, 2023 | 2025-06 (estimated) |
FDA records (last 2 years)
NIH awards 21
- NIH award 5U44NS121562-05 FY2025: $1,294,567 awarded for that fiscal year; activity U44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Automated Seizure Detection for Home Seiz source ↗
- NIH award 5U44NS121562-04 FY2024: $1,298,163 awarded for that fiscal year; activity U44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Automated Seizure Detection for Home Seiz source ↗
- NIH award 5SB1NS100235-07 FY2024: $1,199,931 awarded for that fiscal year; activity SB1 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. REMI Platform for Remote EEG Monitoring source ↗
- NIH award 4U44NS121562-03 FY2023: $1,683,078 awarded for that fiscal year; activity U44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Automated Seizure Detection for Home Seiz source ↗
- NIH award 5SB1NS100235-06 FY2023: $1,167,632 awarded for that fiscal year; activity SB1 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. REMI Platform for Remote EEG Monitoring source ↗
- NIH award 5U44NS121562-02 FY2022: $993,086 awarded for that fiscal year; activity U44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Automated Seizure Detection for Home Seizur source ↗
- NIH award 2SB1NS100235-05A1 FY2022: $1,053,438 awarded for that fiscal year; activity SB1 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. REMI Platform for Remote EEG Monitoring source ↗
- NIH award 1U44NS121562-01 FY2021: $999,853 awarded for that fiscal year; activity U44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Automated Seizure Detection for Home Seizur source ↗
- NIH award 5R44NS100235-04 FY2019: $589,316 awarded for that fiscal year; activity R44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. EEG Patch source ↗
- NIH award 5R44NS100235-03 FY2018: $717,796 awarded for that fiscal year; activity R44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. EEG Patch source ↗
- NIH award 2R44NS100235-02 FY2017: $751,454 awarded for that fiscal year; activity R44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. EEG Patch source ↗
- NIH award 1R43HL134420-01A1 FY2017: $225,452 awarded for that fiscal year; activity R43 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Tessa Sleep Quality Monitoring source ↗
- NIH award 1R43NS100235-01 FY2016: $230,579 awarded for that fiscal year; activity R43 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. EEG Patch source ↗
- NIH award 5R44NS064661-08 FY2016: $778,332 awarded for that fiscal year; activity R44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Epoch Telemetry System for Long-Term Monito source ↗
- NIH award 5R44NS064661-07 FY2015: $780,753 awarded for that fiscal year; activity R44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Epoch Telemetry System for Long-Term Monito source ↗
- NIH award 2R44NS064661-06A1 FY2014: $794,403 awarded for that fiscal year; activity R44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Epoch Telemetry System for Long-Term Moni source ↗
- NIH award 5R44NS064661-05 FY2013: $601,418 awarded for that fiscal year; activity R44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Epoch Telemetry System for Long-Term Monito source ↗
- NIH award 5R44NS064661-04 FY2012: $605,137 awarded for that fiscal year; activity R44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Epoch Telemetry System for Long-Term Monito source ↗
- NIH award 2R44NS064661-03 FY2011: $597,444 awarded for that fiscal year; activity R44 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Epoch Telemetry System for Long-Term Monito source ↗
- NIH award 5R43NS064661-02 FY2010: $349,978 awarded for that fiscal year; activity R43 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Miniature EEG Telemetry Device for Translat source ↗
- NIH award 1R43NS064661-01A2 FY2009: $349,978 awarded for that fiscal year; activity R43 (SBIR); PI LEHMKUHLE, MARK J.; recipient as written: EPITEL, INC., SALT LAKE CITY, UT. Miniature EEG Telemetry Device for Transl source ↗