• 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

Withings Sleep Rx Receives FDA Clearance for Home Sleep Apnea Testing

by Jasmine Pennic 09/09/2024 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

What You Should Know: 

– Withings, a global leader in connected health, has announced that its Sleep Rx sleep apnea device has received clearance from the U.S. Food and Drug Administration (FDA). 

– Sleep Rx represents a significant advancement in the diagnosis of sleep apnea, offering a more convenient and accurate alternative to traditional in-lab testing.

Addressing the Underdiagnosis of Sleep Apnea

Sleep apnea is a serious condition that affects millions of people worldwide. However, it is often underdiagnosed due to the limitations of traditional diagnostic methods. Sleep Rx offers a scalable and accurate solution for home sleep apnea testing.

Key Features & Benefits of Sleep Rx

  • Non-intrusive: Sleep Rx is a comfortable and unobtrusive device that fits under any mattress.
  • Comprehensive Analysis: Provides detailed analysis of sleep, breathing, and cardiovascular activity.
  • Accurate Diagnosis: Clinically validated for the diagnosis of sleep apnea.
  • Easy to Use: Requires minimal setup and provides clear, easy-to-understand results.
  • Improved Diagnosis: Sleep Rx can help to accurately diagnose sleep apnea, even in cases where traditional methods have failed.
  • Increased Access: By offering a home-based testing solution, Sleep Rx can improve access to sleep apnea diagnosis.
  • Improved Patient Outcomes: Early diagnosis and treatment of sleep apnea can lead to better health outcomes.

“We’re thrilled to bring Sleep Rx to the U.S. market,” said Antoine Robiliard, VP of Withings Health Solutions. “Enabling earlier and more precise diagnosis, Sleep Rx creates a new sleep apnea diagnosis and management paradigm. We know that a one-night assessment is not sufficient. By enabling more efficient and lower-cost home-based OSA diagnosis, Sleep Rx could not only reduce the staggering $150 billion annual economic burden of undiagnosed sleep apnea but also significantly improve long-term health outcomes.”

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: FDA Clearance, FDA clearance 510k

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 |