Empatica’s SpO2 algorithm is a key component of the Empatica Health Monitoring Platform, an end-to-end remote patient monitoring solution for clinical trials and already deployed across a large number of global Phase I-IV studies. It is powered by EmbracePlus, a medical-grade wearable featuring PPG, Accelerometer, Gyroscope, Skin Temperature and EDA sensors.
Thanks to its PPG sensor, EmbracePlus provides accurate, FDA-cleared pulse oximetry data directly from the wrist. SpO2 is a critical vital sign that can serve as an endpoint for trials in respiratory illnesses (e.g. COPD, pneumonia), oncology (e.g. chemo-induced pulmonary toxicity), and sleep disorders (e.g. obstructive sleep apnea).
This first-ever PCCP authorization sets the stage for implementing algorithm improvements without requiring new 510(k) applications, meaning trials using the Empatica Health Monitoring Platform and EmbracePlus can benefit from:
The Empatica Health Monitoring Platform received prior FDA 510(k) clearances in November 2022 and November 2023, and this authorization marks Empatica’s sixth FDA clearance overall. It is a testament to Empatica’s unwavering commitment to delivering patient-first, agile and future-ready solutions for clinical researchers.
Empatica
Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. Empatica's FDA-cleared technology platform is used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. Its flagship medical wearable, EmbracePlus, has been developed with HHS, USAMRDC, and the NASA-funded TRISH.
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