"This is a big milestone for our young company," said 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 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."
The company has worked in close partnership with the FDA since early 2015 to understand the unique dynamics of this device, specifically the nanosensor technology. "Our discussions were collaborative and interactive, culminating in this announcement," said Varadan.
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 commercialization, strategic partnerships and continued development of complementary products and applications for chronic disease states.
Nanowear is the leading developer of patented, textile-based nanosensor technology with applications in the cardiac, neurological, industrial, safety, government and sports medicine / performance diagnostics monitoring markets. The company's proprietary technology enables continuous electrophysiological, biometric and biochemical monitoring that provides medical professionals with accurate diagnostic data through a cost-effective and non-invasive wearable solution. Nanowear's core focus on innovation and next-gen technologies will continue to propel the company towards unique and groundbreaking applications for its nanosensors. The company is headquartered in New York, NY, with a research and development center in University Park, PA.
For more information, please visit www.nanowearinc.com, or contact us at the following:
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