Israeli Wearable Device To Monitor Key Body Functions Gets FDA Nod 

An Israeli-made wearable device to monitor the body’s key functions has received approval from the US Food and Drug Administration (FDA). 

The Smart Skin device made by Herzliya-based biotechnology company X-trodes comprises electrode patches that can be placed at any point on the body in order to monitor signals showing brain, cardiac, muscle and eye activity. The customizable patches are wireless and flexible, and do not require gels or other materials to function. 

X-trodes says that while electrophysiological monitoring has traditionally only been available in clinical settings, due to previously cumbersome equipment, the size and ease of use of the new patches mean that patients can now monitor these functions at home or any other location. 

Before it received the clearance, the company successfully completed extensive checks of the system’s accuracy and consistency, which also proved that the technology is equivalent to existing FDA-approved devices that monitor these signals. 

X-trodes will now seek to verify Smart Skin’s suitability for multiple clinical situations, focusing first on cardiovascular functions and sleep monitoring.  

“The X-trodes system is the next generation of wearable and fully wireless solutions, enabling clinicians and researchers to unleash the full potential of medical-grade electrophysiological monitoring,” said X-trodes CEO Ziv Peremen. 

“Gaining FDA clearance affirms the value of this technology and its potential to improve health and wellness through access to real-time electrophysiological data. It will further shorten the path to commercialization for a range of clinical use cases,” he said.