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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.