Nano-sensor technologist Nonowear has received clearance for a remote cardiac monitoring undergarment that it says will collect data on ECG, heart and respiratory rate. 

Nanowear has received FDA Class II 510(k) clearance for its SimplECG product, which transfers data to a web-based portal for review by a physician, by way of a mobile application. The initial version of the product is iPhone-based. 

The move marks the company's first FDA clearance, and reflects Nanowear's strategy of differentiating itself in an otherwise crowded market for wearables.

Nanowear says SimplECG will provide an easier and more patient-friendly means of capturing and transmitting diagnostic data via everyday garments in an effort to monitor heart behaviour and prevent cardiac-related events.

"This is a big milestone for our young company," says co-founder & CEO Venk Varadan. "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."

The company has worked in close partnership with the FDA since early 2015 to understand the dynamics of the device, specifically the nanosensor technology. 

Nanowear says it will now focus its near-term efforts on product commercialisation, strategic partnerships and continued development of complementary products and applications for chronic disease states.