FDA Gives Clearance for Wearable Heart, Lung Monitoring Platform

The US Food and Drug Administration (FDA) had given Class II 510(k) clearance to SimpleSENSE, a first-of-its-kind cloth-based diagnostic platform that provides continuous, simultaneous, and synchronous assessment of the heart, lungs, and upper vascular system.

The approval was granted to Nanowear, a developer of patented, cloth-based nanosensor technology.

“SimpleSENSE marks Nanowear’s second FDA 510(k) clearance and follows our strategy of continued data-driven differentiation in the connected-care and remote diagnostic market,” said Venk Varadan, co-founder and CEO of Nanowear, in a statement.​

“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,” he said.

SimpleSENSE is gender-neutral and size adjustable, and it has been touted to effectively replace the digital stethoscope, multi-channel Holter monitor, Capnogram respiration machine, and blood pressure cuff. This is done by remotely capturing more than 100 million data points per day across cardiac, pulmonary, and circulatory biomarkers.

Spero Theodoroum, MD, Chief Medical Officers of InMode, echoed the importance of this technology during the coronavirus 2019 (COVID-19) pandemic.

“The pandemic is transforming the way healthcare services are accessed and delivered today and for years to come. We are excited about the role that Nanowear will play in the field of remote diagnostics and how it will provide patients around the world access to better outcomes and improved quality of life, regardless of whether they are being cared for in the clinic or in the comfort of their homes,” he said.