• 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

ResApp Awarded CE Mark for Smartphone-Based Diagnostic Test for Respiratory Disease

by Fred Pennic 08/23/2019 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

ResApp Awarded CE Mark for Smartphone-Based Diagnostic Test for Respiratory Disease

ResApp Health, the developers of the world’s first smartphone-based diagnostic test for respiratory disease where one simply coughs into the phone and the machine learning-based algorithm diagnoses the underlying respiratory disease, has received CE Mark certification as a Class IIa medical device.

Significance of CE Mark Certification

CE Mark certification indicates that ResAppDx-EU meets the essential requirements of all the applicable European regulations as a medical device and allows for the sale of ResAppDx-EU in the European Economic Area. The CE Mark approval was supported by data collected in ResApp’s Breath Easy pediatric clinical study.  The Breath Easy study was a double-blind, prospective study which evaluated the efficacy of ResApp’s cough-based diagnosis algorithms in diagnosing acute respiratory disease in children.

The study collected data from 585 patients and demonstrated that ResApp’s algorithms had excellent agreement with a clinical diagnosis. Results from the study were recently published in the peer-reviewed journal Respiratory Research.

CE Mark certification will facilitate further regulatory submissions in Australia, Canada and Singapore. In April, ResApp submitted a De Novo classification request to the US Food and Drug Administration which is currently pending review.

Instantly diagnose and manage respiratory disease using only a smartphone

Most people will develop an acute respiratory tract infection every year and these infections are the most common acute illnesses seen in primary care. Today, acute respiratory disease diagnosis, especially in children, is a complex, subjective process, combining clinical judgement with diagnostic aids such as auscultation with a stethoscope, imaging, blood and sputum tests.

ResAppDx-EU is a mobile software application to be used by clinicians for the diagnosis of lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease and bronchiolitis in infants and children. The software uses machine learning algorithms that analyze a patient’s cough sounds to diagnose disease. ResAppDx-EU is a software-only solution that runs on an off-the-shelf smartphone and does not require any additional hardware or accessories.

Why It Matters

“We are very excited about receiving our first regulatory approval for ResAppDx-EU, our flagship acute diagnostic product,” said Tony Keating, CEO and Managing Director of ResApp. “This is our biggest achievement yet and results from many years of hard work by our dedicated team. For the first time clinicians in Europe will have access to a rapid and accurate diagnostic test for the most commonly seen acute respiratory conditions in children. ResAppDx-EU has the potential to have far-reaching benefits in the healthcare system and we will now rapidly move ahead with our European commercialization strategy.”

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: algorithms, Asthma, De novo classification, Machine Learning, Medical Device, pneumonia, Primary Care, ResApp, respiratory disease

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 |