• 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

FDA Awards 510(k) Clearances for ZEUS System/Zio Watch

by Fred Pennic 07/22/2022 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print
iRhythm + Verily Awarded FDA Clearances on ZEUS System/Zio Watch

What You Should Know:

– Today, iRhythm (a digital health company) and Verily (Alphabet’s life sciences research organization) announced joint FDA 510(k) clearances for the ZEUS System and Zio Watch. Together they create an integrated, prescription-based solution that will improve clinician workflows, care pathways and the patient experience. 

– The ZEUS System is the AI algorithm and solution component of the Zio Watch – a clinical grade, long-term and noninvasive wearable that not only detects atrial fibrillation (AFib) but also characterizes the amount of AFib over time, thus aiding a clinician in diagnosis. iRhythm has what is believed to be the world’s largest repository of ECG data, which is leveraged to develop its proprietary PPG algorithm.

Integrated, Prescription-Based Solution

The Zio Watch with the ZEUS System is an integrated, prescription-based solution that addresses clinician workflows, care pathways and the patient experience. The cleared Zio Watch is a wrist-worn solution that not only detects AFib but also characterizes the amount of AFib over time, thus aiding a clinician in diagnosis. The Zio Watch uses continuous photoplethysmography (PPG), an AI-based algorithm to detect AFib and calculate an AFib burden estimate. A preliminary report is then sent to the patient’s clinician for review, potentially leading to a diagnosis and clinical intervention.

“We are incredibly excited about this important milestone as we make progress in bringing a new monitoring platform to patients who can benefit from it. There is a clear need in the market today for a clinical grade, long-term and noninvasive monitoring solution,” said Quentin Blackford, CEO and President of iRhythm. “iRhythm is focused on redefining the standard of care with earlier insight to predict and prevent disease, and the Zio Watch with ZEUS System provides clinicians a platform that has the potential to meaningfully improve patients’ lives.”

The Zio Watch will be complementary to Zio monitors by adding a modality with longer wear times for patients who require long-term monitoring in order to detect, characterize and manage AFib. The Zio Watch is designed to be a cost-effective, non-invasive monitoring solution and will fully integrate with the Zio service. iRhythm plans to introduce the ZEUS System for a limited market evaluation in 2023.

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: AI, Alphabet, Atrial Fibrillation, care pathways, digital health, ecg, FDA, Life Sciences, Patient Experience, Verily

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 |