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 receives US FDA approval for remote cardiac monitoring undergarment, SimplECG-its first product. 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, with an eye towards the future of the "Connected Self."
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 behavior and prevent cardiac-related events.
John Zimmerman M.D., Nanowear's chief medical officer, said that as healthcare continues to evolve and move beyond the walls of the hospital, easy-to-use and clinically validated solutions are essential to ensure patient compliance and actionable diagnostic insights for physicians and providers.
Co-founder & CEO Venk Varadan remarked that it was a huge milestone for the company . He said that the FDA's decision not only positions them 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.
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. Their discussions were collaborative and interactive, culminating in the announcement.
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.
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