The wireless monitoring platform enables freedom of movement for patients in both healthcare and home settings.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to X-trodes’ smart skin solution, marketed as X-trodes System M, a new wireless wearable technology for advanced electrophysiological monitoring in healthcare and home settings.  

X-trodes’ smart skin is comprised of customizable, dry-printed, multi-modal electrode patches. It monitors a range of biopotential signals from anywhere on the body to acquire EEG, EKG/ECG , EOG (eye movement), and EMG (muscle activity) data. The discreet patches are easy to apply, conforming to the body without requiring gels, wires, or uncomfortable solutions.

The FDA clearance follows completion of a scientific assessment that evaluated the accuracy and consistency of X-trodes’ system. The study showed the performance of the X-trodes technology to be equivalent to that of FDA-cleared clinical electrophysiology devices in measuring EEG, EOG, EMG, and EKG/ECG signals.

“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,” says Ziv Peremen, PhD, CEO of X-trodes, in a release. “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.”

Smart skin is already available to researchers seeking accuracy when measuring electrophysiological signals outside of laboratory settings. Having gained FDA 510(k) clearance, X-trodes will pursue further validations for a range of clinical use cases, with an initial focus on the cardiovascular and sleep monitoring markets.

“Despite an abundance of legacy and new medical device companies entering the market, there is still no single configurable remote monitoring system capable of supporting neurology and cardiology departments in providing the best possible patient experience and outcomes,” says Deganit Barak Shinar, PhD, vice president of clinical affairs at X-trodes, in a release. “Our medical-grade multi-modal solution, which can be deployed across clinical departments and outpatient settings, including the home, has the potential to significantly improve the provision of care.”

Electrophysiological monitoring has traditionally been restricted to clinics, requiring cumbersome hardware and controlled environments to acquire highly sensitive physiological signals. X-trodes’ smart skin encapsulates an entire monitoring lab into a discreet, flexible, and wireless skin patch that provides continuous medical-grade monitoring in any environment.

X-trodes’ technology is backed by more than 15 years of research conducted at Yael Hanein’s Neuro-engineering lab at Tel Aviv University. Its efficacy has been supported by several peer-reviewed studies published in journals, including Nature Scientific Reports and the Journal of Neural Engineering.

Photo caption: X-trodes’ smart skin system

Photo credit: X-trodes