X-trodes’ Smart Skin Earns FDA Clearance for Home-Based Electrophysiological Monitoring

What You Should Know:

– X-trodes, a pioneer in wireless monitoring solutions, has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its Smart Skin solution, marketed as the X-trodes System M.

– The FDA clearance positions X-trodes as a frontrunner in democratizing advanced electrophysiological monitoring. By bringing clinical-grade technology to the home environment, X-trodes paves the way for personalized healthcare solutions, empowering individuals to actively participate in their health management.

What is Smart Skin?

Smart Skin is a wireless, multi-modal electrode patch designed to monitor various biopotential signals from anywhere on the body. It captures data on:

– Brain activity (EEG)

– Cardiac function (EKG/ECG)

– Eye movements (EOG)

– Muscle activity (EMG)

The discreet and comfortable patches require no gels, wires, or messy solutions, making them ideal for continuous monitoring in everyday settings.

Transforming Electrophysiological Monitoring

Historically, electrophysiological monitoring confined patients to clinical settings with cumbersome equipment. X-trodes’ Smart Skin disrupts this paradigm by transforming an entire monitoring lab into a discreet, flexible, and entirely wireless patch. This empowers users with continuous, medical-grade monitoring in their daily lives, fostering personalized healthcare management in various conditions.

X-trodes’ technology rests on over 15 years of research led by Prof. Yael Hanein at Tel Aviv University’s neuroengineering lab. Numerous peer-reviewed studies published in prestigious journals like Nature Scientific Reports and the Journal of Neural Engineering validate its efficacy.

“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 Ziv Peremen, PhD, CEO of X-trodes. “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.”