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The NanoSENSE clinical study is eyeing to validate and provide a way to clear its diagnostic algorithm derived from its size-adjustable, non-invasive, and gender-neutral SimpleSENSE garment.
FREMONT, CA: Nanowear launched NanoSENSE, a heart failure management and alert diagnostic validation study. The study will initially be conducted at Hackensack Meridian Health Systems and Penn State Milton S. Hershey Medical Center.
Using proprietary and first-and-only FDA 510(k) cleared cloth-based sensors, Nanowear has designed SimpleSENSE, a monitoring undergarment and closed-loop machine learning platform that captures and algorithmically scores impedance cardiography, phonocardiography measuring cardiac output and stroke volume, respiratory rate, multi-channel ECG assessing heart rate, thoracic impedance, activity, and posture.
The algorithmic score allows care management teams and physicians with alerts of deteriorating heart failure weeks in advance of a hospitalizing event. It enables the physicians and care teams to manage their patients remotely while cutting down on several costly heart failure-related hospitalizations. A similar multi-vector, the multi-parameter algorithmic scoring thesis is already proved and is getting validated for FDA clearance in implantable devices. However, it is yet to have been achieved via a non-invasive and affordable delivery mechanism. The NanoSENSE clinical study is eyeing to validate and provide a way to clear its diagnostic algorithm derived from its size-adjustable, non-invasive, and gender-neutral SimpleSENSE garment.
People discharged from the hospital after a round of worsening heart failure are readmitted at a rate of 22.5 percent that contributes to more than a million readmissions due to heart failure conditions annually costing the US Healthcare System $40 billion. The aim is to make the use case and form factor as simple and cost-effective as possible, requiring a little to no effort from the patient's end.
Nanowear’s core technology that features cloth-based, dry-contact electrodes provides both impedance cardiography, thoracic impedance, as well as cloth-based, dry electrodes to monitor both lung and heart function. An essential need for remote monitoring, particularly for high-risk patients, is addressed by Nanowear’s non-invasive short-term connected care system.