Nanowear www.nanowearinc.com, the leading connected-care and remote diagnostic platform, today announced it has received FDA Class II 510(k) clearance for a first-of-its-kind cloth-based diagnostic platform, SimpleSENSE. SimpleSENSE is a multi-parameter remote diagnostic undergarment and machine learning digital platform, which simultaneously and synchronously monitors and assesses the heart, lungs, and upper vascular system.
Gender-neutral and size adjustable, the SimpleSENSE platform effectively replaces the digital stethoscope, multi-channel Holter monitor, Capnogram respiration machine, and blood pressure cuff by providing a diagnostic quality monitoring system that remotely captures more than 100 million data points per patient per day across cardiac, pulmonary, and circulatory biomarkers. With the increased need for telemedicine and remote diagnostic monitoring, SimpleSENSE provides a digital tool to assess medical data and trends between these biomarkers in a way that has not been previously available, empowering clinicians to treat patients earlier and more effectively.
“SimpleSENSE marks the company’s second FDA 510(k) clearance and follows Nanowear’s strategy of continued data-driven differentiation in the connected-care and remote diagnostic market,” said Venk Varadan, co-founder and CEO of Nanowear. “In the face of the unexpected and unprecedented COVID-19 public health emergency, Nanowear began working collaboratively with FDA to evaluate a broadened indication for use for SimpleSENSE. Our platform can now efficiently serve the new need for remote diagnostics across primary care, acute illness and procedure, and chronic disease cases.”