Boston, MA — Empatica announces the achievement of a landmark regulatory milestone: the U.S. Food & Drug Administration has authorized Empatica’s pulse oximetry (SpO2) algorithm with a Predetermined Change Control Plan (PCCP), making it the first ever PCCP authorization for a pulse oximetry device.
The PCCP authorization means that Empatica can now update its SpO2 algorithm without requiring a new 510(k) submission. This provides important flexibility to deploy new algorithm enhancements, enabling faster adoption to meet evolving trial needs.
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:
- Faster deployment of algorithm refinements;
- Speedier inclusion and onboarding of diverse patient cohorts, such as those with varying skin tones or specific physiological conditions;
- Ongoing innovation with the same guaranteed safety and quality standards set by the FDA.
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.
Reach out to our team to learn how you can implement wearable SpO2 monitoring and digital endpoints in your trials.
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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.