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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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Portable Electrochemical Sensing Platform for Aflatoxin B1 Detection in Food Matrices

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Food Analytical Methods

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Development and benchtop testing of an aptamer-based sweat sensor for CRP detection

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Microchimica Acta

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Monitoring TNF-⍺ monoclonal antibody via sweat cytokine profiling using the IBD AWARE®: A non-invasive approach to assess therapeutic response

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Elsevier

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Longitudinal tracking of chronic inflammation through Calprotectin and Interleukin-6 using a sweat wearable device

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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.

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