Empatica's remote monitoring platform scores FDA nod for new biomarkers

Empatica announced Thursday that its remote monitoring platform received FDA 510(k) clearance for two new digital biomarkers to measure users' pulse and respiratory rates. The health platform now includes six FDA-cleared digital biomarkers in total.

Chief medical officer Marisa Cruz said the clearance "reflects our continued commitment to rigorous analytical and clinical validation of digital biomarkers for use in clinical research and patient care."

The Empatica health monitoring platform was initially cleared last year to track resting blood oxygen saturation levels, electrodermal activity, peripheral skin temperature and activity associated with movement during sleep. The device is built on data collected by Empatica's FDA-cleared and CE-marked EmbracePlus smartwatch and also includes the company's Care software suite and secure cloud infrastructure.

The company noted that the platform supports 128 digital measures, allowing healthcare professionals and researchers to validate treatments and better understand diseases to improve health outcomes. 

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