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Nanowear gets FDA clearance for remote monitoring clothing

07 Dec '16

2 min read

Nanowear, a leading developer of patented, textile-based nanosensor technology for the cardiac, neurological, industrial, safety, government and sports medicine / performance diagnostics monitoring markets, has announced that it has received FDA Class II 510(k) clearance for its first product, SimplECG, a remote cardiac monitoring undergarment.

SimplECG collects continuous multi-channel ECG, heart rate and respiratory rate data from the garment and transfers it 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.

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

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.

Nanowear co-founder and CEO Venk Varadan said, “This is a big milestone for our young company. 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 market of applications for healthcare alone is a multi-billion-dollar opportunity, but as we look beyond to consumer, industrial, clinical research, military and public sector applications, the addressable market expands exponentially.”

Having spent the last two years focused solely on product development and the regulatory process, Nanowear will now focus its near-term efforts on product commercialisation, strategic partnerships and continued development of complementary products and applications for chronic disease states. (GK)

Fibre2Fashion News Desk – India