• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage
  • Life Sciences
  • Research

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

by Fred Pennic 02/20/2024 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print
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.”

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: FDA Clearance

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Insights

2025 EMR Software Pricing Guide

2025 EMR Software Pricing Guide

Featured Interview

Paradigm Shift in Diabetes Care with Studio Clinics: Q&A with Reach7 Founder Chun Yong

Most-Read

Medtronic to Separate Diabetes Business into New Standalone Company

Medtronic to Separate Diabetes Business into New Standalone Company

White House, IBM Partner to Fight COVID-19 Using Supercomputers

HHS Sets Pricing Targets for Trump’s EO on Most-Favored-Nation Drug Pricing

23andMe to Mine Genetic Data for Drug Discovery

Regeneron to Acquire Key 23andMe Assets for $256M, Pledges Continuity of Consumer Genome Services

CureIS Healthcare Sues Epic: Alleges Anti-Competitive Practices & Trade Secret Theft

The Evolving Role of Physician Advisors: Bridging the Gap Between Clinicians and Administrators

The Evolving Physician Advisor: From UM to Value-Based Care & AI

UnitedHealth Group Names Stephen Hemsley CEO as Andrew Witty Steps Down

UnitedHealth CEO Andrew Witty Steps Down, Stephen Hemsley Returns as CEO

Omada Health Files for IPO

Omada Health Files for IPO

Blue Cross Blue Shield of Massachusetts Launches "CloseKnit" Virtual-First Primary Care Option

Blue Cross Blue Shield of Massachusetts Launches “CloseKnit” Virtual-First Primary Care Option

Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density

Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density

2019 MedTech Breakthrough Award Category Winners Announced

MedTech Breakthrough Announces 2025 MedTech Breakthrough Award Winners

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |