Nanowear obtains FDA 510(k) clearance for SimplECG

4 December 2016 (Last Updated December 4th, 2016 18:30)

The US Food and Drug Administration (FDA) has granted Class II 510(k) clearance to Nanowear’s remote cardiac monitoring undergarment, SimplECG.

The US Food and Drug Administration (FDA) has granted Class II 510(k) clearance to Nanowear’s remote cardiac monitoring undergarment, SimplECG.

SimplECG has been designed to collect continuous multi-channel ECG, heart rate and respiratory rate data from the garment and relays it to a web-based portal through a mobile application for review by a physician.

The initial version of the product is compatible to iPhone.

"This is the first step and foundation of what we believe to be an extensive array of applications for our nanosensor technology."

Nanowear co-founder and CEO Venk Varadan said: “The FDA’s decision not only positions us for commercial opportunities in remote cardiac monitoring, but more importantly, it provides accreditation of the company’s one-of-a-kind, cloth-based sensor technology as medical-grade.

“This is the first step and foundation of what we believe to be an extensive array of applications for our nanosensor technology including numerous other electrical, biometric and biochemical signals that can be measured directly from the skin without conductive gels, adhesives or skin preparation.”

SimplECG is expected to offer an easier and more patient-friendly ways of capturing and relaying diagnostic data through everyday garments in order to monitor heart behavior and prevent cardiac-related events.

The company uses its proprietary technology to facilitate continuous electrophysiological, biometric and biochemical monitoring to provide accurate diagnostic data to the medical professionals through a cost-effective and non-invasive wearable solution.