Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data

A Study to Evaluate the Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data in Healthcare and Remote Settings

Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements.

Study design: A single-site, non-significant risk, open-label, prospective non-randomized clinical investigation designed to validate the accuracy of the various physiological parameters that the Wearable Sensor Patches acquire and the system processes.

Inclusion Criteria:

1. Male or female volunteers, at least 18 years of age at the time of screening visit;
2. Fluent in English;
3. The subject is willing to comply with the protocol specified evaluations;
4. Subject is willing and cognitively able to sign informed consent

Exclusion Criteria:

1. Pregnancy;
2. Positive urine drug screen
3. History of active (clinically significant) skin disorders;
4. History of allergic response to silicones or adhesives;
5. Subjects with electronic implants of any kind (e.g. pacemaker)
6. History of sleep disorders or self-reported insomnia or other sleep conditions;
7. Broken, damaged or irritated skin or rashes near the sensor application sites;
8. Subjects that are MC10 employees or shareholders, or a spouse or child of an MC10 employee or shareholder;
9. Subjects who are physically or cognitively unable to normally perform activities of daily living, assessed at the discretion of the investigator.