Nanowear has secured class II 510(k) clearance from the US Food and Drug Administration (FDA) for its SimplECG remote diagnostic monitoring device.
The device will collect continuous multi-channel ECG, heart rate and respiratory rate data from the garment.
Later, the data will be transferred to a web-based portal through mobile application for review by a physician.
The device will capture and transmit diagnostic data via everyday garments, helping to monitor heart behavior and prevent cardiac-related events.
According to the company, the initial version of the product is iPhone-based
Nanowear chief medical officer Dr John Zimmerman said: "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 co-founder and CEO Venk Varadan 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.”
Nanowear is engaged in the development of patented and textile-based nanosensor technology with applications in the cardiac, neurological, industrial, safety, government and sports medicine / performance diagnostics monitoring markets.
The firm’s technology allows continuous electrophysiological, biometric and biochemical monitoring, providing medical professionals with cost-effective and non-invasive wearable solution.