Israeli bio-convergence company X-trodes has received the US Food and Drug Administration (FDA) 510(k) approval for its Smart Skin solution, marketed as X-trodes System M.
The Smart Skin is a new wireless wearable technology that comprises customisable dry-printed multi-modal electrode patches to enable advanced electrophysiological monitoring.
It monitors a wide range of biopotential signals to determine brain activity (EEG), cardiac monitoring (EKG/ECG), eye movement (EOG), and muscle activity (EMG).
X-trodes said that the electrode patches are easy to apply and comfortable to wear, as they conform to the body, without needing gels, wires, or uncomfortable solutions.
The FDA approval follows the completion of an extensive scientific assessment that evaluated the accuracy and consistency of X-trodes System M.
In the study, X-trodes technology performed equivalent to FDA-approved clinical electrophysiology devices in measuring EEG, EOG, EMG, and EKG/ECG signals.
X-trodes CEO Ziv Peremen said: “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.
“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.”
X-trodes has developed wearable technology based on more than 15 years of research at Tel Aviv University neuro-engineering lab and scientifically validated patents.
The efficacy of the device has been validated by several studies published in peer-reviewed journals, including Nature Scientific Reports and the Journal of Neural Engineering.
Smart Skin is already available to researchers seeking superior accuracy when measuring electrophysiological signals outside of laboratory settings.
With the FDA 510(k) approval in place, X-trodes will pursue further validations for a wide range of clinical use cases, initially focusing on cardiovascular and sleep monitoring markets.
Traditionally, electrophysiological monitoring is restricted to clinics, requiring complicated hardware and controlled environments to acquire highly sensitive physiological signals.
X-trodes said that its Smart Skin solution encapsulates an entire monitoring lab into a small, flexible and completely wireless skin patch.
It provides continuous medical-grade monitoring in any environment comfortable for users.
X-trodes clinical affairs vice president Deganit Barak Shinar said: “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.
“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.”
