Empatica has received US Food and Drug Administration (FDA) 510(k) clearance for two new digital biomarkers, namely pulse and respiratory rate, for its health monitoring platform.
Empatica’s health monitoring platform is often used in clinical trials for remote patients. In addition to the two newly cleared biomarkers the platform also includes four other FDA-cleared digital biomarkers, namely electrodermal activity, blood oxygen saturation (SpO₂), skin temperature and activity associated with movement during sleep.
Incorporating technology in clinical trials has been an emerging trend in recent years. According to GlobalData’s Pharma Intelligence Centre, remote patient monitoring and telemedicine are one of the most used virtual components in decentralised clinical trials (DCT).
The use of remote monitoring devices extends beyond clinical trials. The remote monitoring device market is forecasted to be worth $760m in 2030, as per GlobalData analysis.
Apart from the FDA-cleared biomarkers, Empatica’s health monitoring platform supports 128 digital measurements for both clinical and research use. The digital biomarker data is collected by the EmbracePlus wearable.
Empatica also offers a full-stack remote health monitoring and data collection solution, along with access to raw data from EmbracePlus sensors.
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Remote monitoring wearable devices have been increasing in prevalence and can track multiple health parameters. Even mainstream tech companies have jumped on this trend, both Apple and Google offer health sensors as part of their phones.
In October, Apple device imports were halted by the US due to claims of copyright infringement claims by Masimo. The US International Trade Commission (USITC) ruling was also accompanied by a cease-and-desist notice.