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Nanowear Receives FDA Clearance for Smart Cardiac Undergarment

Nanowear’s latest product is merging apparel and healthcare together.

The textile technology company received FDA Class II 510(k) clearance for SimplECG, a remote cardiac monitoring garment. As Nanowear’s first product, SimplECG collects heart rate, respiratory rate and multi-channel ECG data from the garment and transfers information to physicians with an iPhone application.

“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,” said Nanowear CEO and co-founder Venk Varadan. “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.”

Nanowear’s FDA clearance demonstrates the company’s efforts of distinguishing itself among other key wearable players. With its smart abilities, SimplECG will provide a more seamless process for transmitting diagnostic data with everyday clothing. The product will be crucial for determining heart rates and preventing cardiac-related events, including artery blockages and heart disease.

“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,” Nanowear chief medical officer John Zimmerman, M.D., said.

Since early 2015, Nanowear has worked closely with the FDA to understand the product’s nanosensor technology. After spending two years on SimpleECG’s development, the company will now focus on future strategic partnerships and the product’s commercialization.

“This is a big milestone for our young company,” Varadan said. “The market for 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.”