Nanowear, a NYC-based developer of cloth-based nanosensors and monitoring systems, has entered a clinical trial collaboration with two major NY/NJ-area hospital systems to test for vital signs which may be predictive of an advancing case of COVID-19. 

The goal of the investigative teams at Hackensack Meridian Health, the largest health system in north and central New Jersey with 17 hospitals plus 500 patient care sites, and Maimonides Medical Center of Brooklyn, affiliated with Northwell Health, is to determine and assess patients for early signs of the ‘cytokine storm’ in the heart and lungs which indicates inflammation within the circulatory system, often leading to severe complications and death in COVID patients. The clinical trial will monitor patients with confirmed or suspected COVID-19. The release is not specific as to whether the garment will be issued to patients monitored solely in the hospital or inclusive of patients still at home.

Nanowear’s SimpleSENSE adjustable undergarment continuously captures key physiological signs related to the onset of COVID–real-time ECG, systolic and diastolic blood pressure, blood flow hemodynamics, respiration, lung volume and fluid, and temperature. The vital signs are then transmitted via a mobile app to a physician portal for monitoring and interpretation.  

The garment test is also significant as it is a contactless monitoring system–highly applicable to contagious diseases.

Last July, SimpleSENSE launched in a heart failure management clinical trial with Penn State Hershey Medical Center in Pennsylvania and Hackensack Meridian. The patented cloth-based nanotechnology sensors can capture up to 120 million data points per patient per day. The HF management trial was designed to validate and provide a pathway to clear its own diagnostic algorithm generated from the garment. The SimpleSENSE device and mobile platform have been submitted to FDA for Class II 510(k) clearance.  Also mHealth Intelligence.

This may be the Year of the Sensor. Human contact is out, remote monitoring is in. Earlier this week, we covered Philips integrating BioIntelliSense‘s BioSticker into its RPM systems. During 2018-2019, we profiled Doncaster UK-based MediBioSense, which uses the VitalPatch from VitalConnect. They recently announced that an enhanced VitalPatch suitable for seven-day use and body temperature sensing received CE Class IIa medical certification as well as FDA clearance. We last covered them when MBS adopted the Blue Cedar app security system in 2018, but based on their website press section, much has happened since in extending their sensor-based technologies. This Editor will try to catch up with Simon Beniston of MBS.