Nanowear gains FDA approval for first-of-its-kind wearable: undergarment that tracks cardiac health
NEW YORK -- Nanowear, an early stage developer of cloth-based diagnostic monitoring nanosensor technology, on Thursday 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 is a big milestone for our young company," stated Venk Varadan, CEO Nanowear. "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," he said. "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."
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.
"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," stated John Zimmerman, chief medical officer, Nanowear.
The company has worked in 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," Varadan said.
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.