COMPANY
Empatica
Empatica's regulatory team provides direct support throughout the submission process, including device validation documentation, protocol-specific IFU materials, and post-market surveillance reporting. Empatica provides algorithm documentation, validation study references, and regulatory submission support materials, including device descriptions suitable for IND, NDA, and BLA filings, through its dedicated regulatory affairs team. From company website Source · Oct 13, 2026
Timeline
- Trial start Not phased (device or behavioral study): Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking source ↗
- Trial start Not phased (device or behavioral study): EmbracePlus SpO2 Accuracy Validation source ↗
- Trial start —: EmbracePlus, Care App and Aura Usability Study source ↗
- Trial start Not phased (device or behavioral study): Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System source ↗
- Trial start Not phased (device or behavioral study): Embrace: Seizure Characterization source ↗
Clinical trials (lead sponsor) 5
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06275685 | Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Apr 11, 2024 | 2026-06 (estimated) |
| NCT04964609 | EmbracePlus SpO2 Accuracy Validation | Not phased (device or behavioral study) | Completed | Jun 16, 2021 | Nov 21, 2022 (actual) |
| NCT04807608 | EmbracePlus, Care App and Aura Usability Study | Not listed | Completed | May 31, 2021 | May 31, 2022 (actual) |
| NCT03207685 | Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | Jun 30, 2017 | Jan 15, 2019 (actual) |
| NCT03206502 | Embrace: Seizure Characterization | Not phased (device or behavioral study) | Unknown status (ClinicalTrials.gov) | 2016-05 | 2026-05 (estimated) |