Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
Empatica S.r.l.The Empatica Health Monitoring Platform is a wearable device system that monitors various physiological parameters such as pulse rate, respiratory rate, oxygen saturation, and skin temperature by collecting sensor data, which is analyzed using AI algorithms. It enables healthcare professionals to review patients' physiological data remotely and retrospectively to assess their condition, improving patient monitoring in home healthcare settings.
Intended Use
The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. It supports retrospective review of pulse rate, oxygen saturation under no-motion conditions, respiratory rate under no-motion conditions, peripheral skin temperature, electrodermal activity, and activity associated with movement during sleep.
Technology
A wrist-worn wearable device collects raw sensor data such as photoplethysmography (PPG), temperature, accelerometer, and electrodermal activity data. Data are wirelessly transmitted via Bluetooth to a paired mobile device where physiological parameters are computed using software modules. Data and results are then transmitted to a cloud platform for storage, further analysis, and access by healthcare professionals. The device uses AI algorithms including a machine-learning based pulse oximetry (SpO2) quality indicator to assess signal quality and compute metrics.
Performance
Performance testing included bench and clinical testing of physiological parameter computations such as pulse rate, respiratory rate, SpO2, skin temperature, electrodermal activity, and activity counts. Performance metrics (accuracy, resolution, range) were shown to be equivalent or non-inferior to the predicate device. The machine learning-based SpO2 quality indicator was validated against the cleared algorithm with non-inferior sensitivity, specificity, and error rates.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/11/2024
8 months - 2
FDA Approval
6/6/2025
Other devices from Empatica S.r.l.
- Embrace2018 • 510K
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