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The Science Behind EnLiSense

In the News

Researchers’ Sweat-Based Sensor May Help Improve Sleep Quality

Peer Reviewed Science

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Electrochemical Immunoassay for Capturing Capsular Polysaccharide of Burkholderia pseudomallei: Early Onsite Detection of Melioidosis

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ACS Infectious Diseases

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Longitudinal assessment of sweat-based TNF-alpha in inflammatory bowel disease using a wearable device

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Nature Scientific Reports

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Continuous monitoring of CRP, IL-6, and calprotectin in inflammatory bowel disease using a perspiration-based wearable device

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Inflammatory Bowel Diseases

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Longitudinal monitoring of IL-6 and CRP in inflammatory bowel disease using IBD-AWARE

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Biosensors and Bioelectronics: X

Important Disclaimer

Guidance for Use and Regulatory Status

EnLiSense devices (IBD AWARE, SWEAT AWARE, and CORTI) are for general wellness in healthy individuals, supporting health awareness, fitness, and lifestyle insights. These products are positioned as low-risk general wellness devices under the FDA's "General Wellness: Policy for Low-Risk Devices" guidance issued January 6, 2026. They provide comprehensive wellness monitoring that continuously and non-invasively tracks chemical biomarkers present in sweat. Please note that our devices are not FDA-cleared and cannot be used for medical diagnostic purposes. We do provide our wearable products for clinical studies and research conducted under Institutional Review Board (IRB) oversight. The EnLiSense Wellness Platform holds commercial certifications for the general wellness category, including the CE Mark (EU), UK CA Mark (UK), and certified to FCC (USA).
 

Non General Wellness Use Requires Clinical Oversight
Medical applications, including monitoring or managing diseases are still under investigation. Investigational use require supervision by qualified healthcare professionals in clinical or research settings.
 

No Medical Claims
Mentions of biomarkers or health conditions reflect research goals and are not evaluated by the FDA. All information is for education and wellness only, not as medical advice.
 

Consult Healthcare Professionals
Consult healthcare providers regarding medical concerns or symptoms. Device data does not replace professional medical advice, diagnosis, or treatment. Seek immediate care for urgent symptoms.
 

Limitations
Users accept all risks with device use. EnLiSense is not responsible for health outcomes from device use or data interpretation. Product features and capabilities may change as development continues.

© 2023 - 2026 by EnLiSense | Terms of Service & Privacy Policy

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