NEW YORK, July 22, 2019 /PRNewswire/ — Nanowear, the leading nanotechnology-based connected-care and remote monitoring platform, today announced the clinical launch of NanoSENSE, a Heart Failure Management and Alert Diagnostic Validation Study. The study will initially be conducted at Penn State Milton S. Hershey Medical Center and Hackensack Meridian Health Systems.
Utilizing proprietary and first-and-only FDA 510(k)-cleared cloth-based nanosensors, Nanowear has developed SimpleSENSE, a monitoring undergarment and closed-loop machine learning platform, which captures and algorithmically scores phonocardiography, impedance cardiography measuring stroke volume and cardiac output, multi-channel ECG assessing heart rate and heart rate variability, respiratory rate, thoracic impedance, activity, and posture.
The algorithmic score provides physicians and care management teams with alerts of worsening heart failure weeks in advance of a hospitalizing event. This allows physicians and care management teams to manage their patients remotely while reducing the number of costly heart failure-related hospitalizations. A similar multi-parameter, multi-vector algorithmic scoring thesis has been proven and validated for FDA clearance in implantable devices, but has yet to have been achieved through a non-invasive and cost effective delivery mechanism. The NanoSENSE clinical study aims to validate and provide a pathway to clear its own diagnostic algorithm generated from its non-invasive, size adjustable, and gender neutral SimpleSENSE garment.