The US Meals and Drug Administration (FDA) has granted Empatica 510(okay) clearance for 2 new digital biomarkers for its Empatica Well being Monitoring Platform: respiratory charge and pulse.
With the addition of respiratory charge and pulse, the Empatica Well being Monitoring Platform now contains six FDA-cleared digital biomarkers. These are among the many 128 digital measures supported by the platform.
“This clearance displays our continued dedication to rigorous analytical and medical validation of digital biomarkers to be used in medical analysis and affected person care,” says Marisa Cruz, chief medical officer at Empatica, in a launch. “The Empatica Well being Monitoring Platform is a number one instance of how dependable, correct, and intuitive expertise can assist improvement of novel therapeutics and enhance affected person outcomes.”
The Empatica Well being Monitoring Platform is a full-stack distant well being monitoring and information assortment answer for analysis and healthcare professionals, constructed on information collected by the corporate’s medical-grade EmbracePlus wearable. Along with the EmbracePlus wearable, the Empatica Well being Monitoring Platform additionally contains Empatica’s proprietary Care software program suite, safe cloud infrastructure, and clinically validated digital biomarkers.
The Empatica Well being Monitoring Platform acquired its preliminary FDA clearance in November 2022. Included inside that clearance had been clinically validated digital biomarkers used to watch electrodermal exercise, SpO2, pores and skin temperature, and motion throughout sleep.
Past the FDA-cleared measures supplied, the Empatica Well being Monitoring Platform additionally presents entry to uncooked information from the EmbracePlus sensors, and over 100 research-grade biomarkers.
Picture caption: Empatica receives FDA 510(okay) clearance for 2 new digital biomarkers for its Empatica Well being Monitoring Platform
Picture credit score: Empatica