FDA Clears Wearable Heart and Respiratory Rate Monitor

A cardiac and respiration monitoring undergarment device has received Class II 510(k) clearance from the US Food & Drug Administration (FDA) to enable remote collection of continuous multi-channel ECG, heart rate, and respiratory rate data from a novel diagnostic nanosensor technology. The data are transferred to a web-based portal for review by a physician, by way of a mobile application.

The transformative wearable device, SimplECG, was developed by Nanowear (New York City, NY, USA), an early stage developer of cloth-based diagnostic monitoring nanosensor technology, which differentiates Nanowear 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 behavior and help prevent cardiac-related events such as heart attacks. The initial version of SimplECG is iPhone-based.

"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," said John Zimmerman, MD, Nanowear's Chief Medical Officer.

"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."

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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