Withings ECG App

by Withings  · Based in France → — Empowering personal health with medical-grade cardiovascular monitoring.
Cardiology Emergency Medicine Internal Medicine
Website
Claim this tool
Is this the maker? Claim the company →

Requires compatible withings device; withings app is free.
Regulatory Status Disclosed

Overview

The Withings ECG App is a software-only medical device designed for use with compatible Withings ScanWatch models to create, record, store, transfer, and display single-channel electrocardiograms (ECG) similar to a Lead I ECG. It is intended for over-the-counter (OTC) use and determines the presence of atrial fibrillation (AFib), sinus rhythm, and high heart rate (100-150 bpm) on a classifiable waveform. The app is not recommended for users with other known arrhythmias and is not intended for individuals under 22 years old. ECG data displayed by the app is for informational use only, and users are not intended to interpret or take clinical action without consulting a qualified healthcare professional. The ECG waveform supplements rhythm classification to discriminate AFib from sinus rhythm and is not a replacement for traditional diagnostic or treatment methods. The Withings App (formerly Health Mate) serves as the companion application, allowing users to view results, track history, and easily share data with their physicians as PDF reports.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Single-lead ECG recording (Lead I equivalent)
  • Atrial Fibrillation (AFib) detection
  • Sinus rhythm detection
  • High heart rate detection (100-150 bpm)
  • Companion mobile app for data visualization and history
  • Ability to share ECG reports as PDFs with physicians
  • Over-the-counter (OTC) use
  • Integration with Withings ScanWatch devices
  • AI-powered insights (Withings+ subscription)
  • Cardiologist reviews of ECG data (Withings+ subscription)

Use Cases

  • Early detection and monitoring of Atrial Fibrillation (AFib)
  • Personal tracking of heart rhythm and rate for health-conscious individuals
  • Facilitating data sharing with healthcare professionals for informed discussions
  • Remote monitoring of cardiovascular health
  • Supplementing traditional diagnostic methods for heart conditions
  • Chronic disease management (as part of Withings Health Solutions)

What Physicians Need to Know

ECG/EKG Analysis Capability
The Withings ECG App, used with devices like ScanWatch and BPM Core, records a single-lead ECG (similar to Lead I). It automatically classifies recordings into Atrial Fibrillation (AFib), normal sinus rhythm, high heart rate (100-150 bpm without AFib), and low heart rate (<50 bpm). The ScanWatch 2's updated algorithm offers 8 distinct classifications.
Arrhythmia Detection Accuracy
In clinical studies, the Withings ECG App demonstrated 99.7% sensitivity in classifying AFib (HR 50-150 bpm) and 99.8% specificity in classifying normal sinus rhythm (HR 50-150 bpm) in classifiable recordings. The Cardio Check-Up service, leveraging the ECG data, can identify over 10 types of arrhythmias.
Cardiac Monitoring Integration
ECG data is stored and displayed within the Withings Health Mate app, allowing users to track long-term heart rate trends and ECG records. Results can be shared with healthcare professionals as a PDF. Withings devices sync data via Wi-Fi or Bluetooth to the app.
AHA/ACC Guideline Alignment
Withings ScanWatch devices, which utilize the ECG App, are FDA-cleared in the US. The ECG feature was tested and cleared under Rx by the FDA, with Withings working towards making it available without a prescription. The BPM Core is compliant with European medical device standards.
Real-Time Alert Capability
The app provides irregular heart rhythm notifications suggestive of AFib. It also alerts users to high or low heart rates when they have been inactive for at least 10 minutes. Users can take an on-demand ECG and receive results within 30 seconds.
Physician Tip

The Withings ECG App serves as a valuable screening and monitoring tool for patients, particularly for detecting Atrial Fibrillation (AFib) and monitoring heart rate trends. Physicians should emphasize that it is not a diagnostic device for all cardiac conditions, nor does it detect heart attacks or ischemic events. The single-lead ECG provides a snapshot, and while highly accurate for AFib detection, clinical context and further diagnostic testing (e.g., 12-lead ECG) are crucial for definitive diagnosis and management. Encourage patients to share the PDF reports, which include the raw ECG waveform and rhythm analysis, for comprehensive review. The 'Cardio Check-Up' service, if available and subscribed to, offers an additional layer of professional review by a cardiologist, which can be beneficial for interpreting complex or concerning readings.

The Withings ECG App is deeply integrated within the Withings ecosystem, primarily connecting with Withings ScanWatch and BPM Core devices via the Withings Health Mate app. This app acts as a central hub for all health data, including ECGs, heart rate, activity, and sleep. Data can be easily exported as a PDF for sharing with healthcare providers. For iOS users, the Cardio Check-Up service can also analyze ECGs from Apple Watch via Apple Health integration. This robust integration facilitates a holistic view of a patient's health metrics.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Requires compatible withings device; withings app is free.
  • The Withings ECG App functionality is included with compatible Withings smartwatches (e.g., ScanWatch series)
  • The companion Withings App is free to download and use
  • An optional premium subscription, Withings+, offers enhanced features including AI-powered insights and ECG-powered cardiologist reviews: $9.95/month or $99.50/year (USD)
DeploymentMobile (iOS, Android)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Withings ECG App is cleared by the FDA under 510(k) Number K240795. It is a software-only device intended for use with ScanWatch to create, record, store, transfer, and display single-channel ECG, determining the presence of atrial fibrillation (AFib), sinus rhythm, and high heart rate (100-150 bpm).
Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Internal Medicine

What the Web Says

The Withings ECG App, used in conjunction with Withings devices like the ScanWatch, generally receives positive feedback for its ability to track and detect atrial fibrillation (AFib) and other cardiac irregularities, with some users reporting it as life-saving. It is often praised for its user-friendly interface and clear presentation of health metrics, making it accessible for both casual users and those closely monitoring their cardiovascular health. However, some users have experienced issues with the app's functionality, including difficulties with setup, inconsistent sleep tracking, and occasional glitches.

Overall: Mixed

Strengths

  • Detects atrial fibrillation (AFib) and other cardiac irregularities.
  • Provides medically accurate results for ECG and blood pressure.
  • User-friendly interface that explains health metrics clearly.
  • Ability to share ECG data with medical professionals.
  • Long battery life of associated devices (e.g., ScanWatch) compared to other smartwatches.
  • Cardiologist review service available for inconclusive ECG readings.

Limitations

  • ECG function may require a prescription in some regions (e.g., US).
  • Some features may be blocked or require a tutorial to enable.
  • Inconsistent or inaccurate sleep tracking reported by some users.
  • App can be tricky to navigate or have a confusing layout.
  • Customer service has been described as poor or non-existent by some users.
  • Lack of continuous heart rate monitoring on some devices (e.g., Move ECG).

Based on reviews from: Reddit, techbuzzireland.com, Live Science, TechRadar, Android Authority, Withings Europe, Withings USA, MedGrade, Apple App Store, Geekanoids, Wareable

Last updated: 2026-07-21

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Withings ECG App

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

FDA
Withings ECG App Receives FDA Clearance for ScanWatch 2
The Withings ECG App, a software-only device used with ScanWatch, received FDA clearance (K240795) on June 15, 2025. It is intended for over-the-counter use to create, record, store, transfer, and display single-channel ECGs similar to Lead I, and to determine the presence of atrial fibrillation, sinus rhythm, and high heart rate.
2025-06
Withings Support
Withings ECG App Update on ScanWatch 2: Enhanced AFib Detection
Withings announced a significant enhancement to the ECG Atrial Fibrillation (AFib) detection feature on ScanWatch 2 with the 2871 Firmware update. The Withings ECG App is now available without requiring a cardiologist's review of the first ECG, and features a new algorithm for more detailed atrial fibrillation detection.
2025-07
Withings Support
Clinical Validation of the ScanWatch 2 ECG feature (Withings ECG App Study)
The ScanWatch 2 ECG feature, integrated into the ScanWatch 2, underwent a clinical study (Withings ECG App Study) to confirm its ability to generate a medical-grade ECG and accurately identify atrial fibrillation and sinus rhythm. The study enrolled 694 patients and demonstrated 99.7% sensitivity in classifying AFib and 99.8% specificity in classifying normal sinus rhythm in classifiable recordings.
2025-07
Android Portal
Withings ScanWatch 2: A Hybrid Smartwatch with Medical-Grade ECG
The Withings ScanWatch 2 is highlighted as a distinctive premium smartwatch offering 30-second medical-grade ECG with AFib detection via the Withings ECG App, continuous heart rate tracking, and a 35-day battery life. It combines analog design with advanced health tracking and is HSA/FSA eligible.
2026-06
Withings Support
Withings ECG App FAQs and Medical Approval
The Withings ECG App has received FDA clearance in the United States and CE medical certification in Europe, confirming its medical accuracy through several clinical studies. Users can take an ECG in 30 seconds, view results on the watch or in the app, and easily share them with a doctor.
2025-07
Physician Ai Tools
Withings ECG App vs. Bunkerhill AVC: AI in Cardiology
A comparison highlights the Withings ECG App as a consumer-facing mobile application integrated with a wearable device, focused on personal health monitoring for atrial fibrillation detection. It is FDA-cleared and offers transparent pricing, with core functionality included with compatible devices.
unknown
Withings USA
Withings ECG App Enables AFib Detection on ScanWatch Nova Brilliant Edition
The Withings ECG App enables the detection of atrial fibrillation through ECG readings on the ScanWatch Nova Brilliant Edition, a feature cleared by the FDA. The app also provides irregular rhythm notifications and allows users to view and share results with their doctor.
2025-08
Patsnap Synapse
Clinical Trial: Validation of HWA10 With Withings ECG-app for the Detection of Atrial Fibrillation
A clinical trial (NCT05316350) titled 'Validation of HWA10 With Withings ECG-app for the Detection of Atrial Fibrillation' is listed as completed, indicating ongoing research and validation efforts for the Withings ECG App.
2025-09

Videos

Product demos, reviews, and walkthroughs for Withings ECG App.

View all on YouTube

Frequently Asked Questions

The Withings ECG App, used with compatible devices like the ScanWatch, employs an AI algorithm to analyze single-lead ECG recordings for the detection of atrial fibrillation (AFib) and to classify the rhythm as normal sinus rhythm or high heart rate (no detected AFib with heart rate 100-150 bpm). Its primary clinical application for physicians is to serve as an initial screening tool for AFib, potentially aiding in earlier detection and management of this arrhythmia in suitable patients, though it is not intended to replace traditional diagnostic methods.
The Withings ECG App, when used with compatible devices such as the ScanWatch, has received FDA clearance in the United States and CE marking in Europe for its ability to detect atrial fibrillation or normal sinus rhythm from a single-lead ECG. These clearances indicate that the device and its associated software meet specific safety and performance standards for their intended use as an over-the-counter (OTC) device.
Withings states that it adheres to strict data privacy regulations, including GDPR in Europe and HIPAA in the United States, for the protection of patient health data. Data is encrypted both in transit and at rest, and Withings is ISO 27001 and HDS certified, ensuring that AI processing of ECG data is conducted with patient privacy and security as a priority. Users also have control over their data, including options for deletion and sharing with third-party applications with explicit consent.
Studies have shown the Withings ECG App's AI, when used with ScanWatch, to have high sensitivity and specificity for detecting atrial fibrillation when compared to a 12-lead ECG interpreted by a cardiologist. For instance, one study reported a sensitivity of 0.963 and specificity of 1.000 for AFib detection, excluding other arrhythmias and noise. While it serves as a valuable screening tool, it is not intended to replace a full diagnostic 12-lead ECG or professional medical interpretation for definitive diagnosis.
The Withings ECG App's AI is primarily designed to detect atrial fibrillation and normal sinus rhythm, and it may not identify other arrhythmias or cardiac conditions. Limitations include the quality of the single-lead recording, potential for artifacts, and the possibility of false positives or negatives, necessitating clinical correlation and further diagnostic testing when indicated. It is not intended for use by individuals under 22 years old, or those with pacemakers, ICDs, or other implanted electronic devices, and cannot check for signs of heart attacks.
The Withings ECG App itself is typically free to download and use with compatible Withings devices, such as the ScanWatch, which are purchased by the patient as a one-time hardware investment. While the basic ECG functionality is free, Withings offers a premium subscription service, Withings+, which provides enhanced features like AI-powered insights and ECG-powered cardiologist reviews for an additional monthly or yearly fee.
Withings Health Solutions offers remote patient monitoring (RPM) solutions that integrate with virtually every EHR platform, allowing seamless data synchronization, device ordering, billing, and alerts management for healthcare providers. For individual users, the Withings App allows for the export of ECG recordings as PDF files or through a secure HealthLink, which can then be shared with healthcare professionals and manually incorporated into EHRs. This facilitates clinical workflow by providing physicians with accessible historical ECG data for review.

Compare Withings ECG App

VS
Withings ECG App vs Sleepiz One+
Cardiology AI Adjacent · 65/100
The Withings ECG App focuses on active, on-demand single-lead ECG recordings for detecting AFib and high heart rate, primarily for users who want to monitor their cardiovascular health…
VS
Withings ECG App vs EchoNext
Cardiology AI Adjacent · 65/100
The Withings ECG App and EchoNext are adjacent tools in cardiology AI, both utilizing ECG data but with distinct applications. Withings focuses on personal, over-the-counter monitoring for conditions…
VS
Acumen Hypotension Prediction Index – EV1000 Clinical Platform vs Withings ECG App
Cardiology AI Adjacent · 60/100
Tool A is designed for acute clinical settings, using machine learning to predict hypotensive events and provide hemodynamic insights to clinicians. In contrast, Tool B is a consumer-grade…
VS
IRNF App vs Withings ECG App
Cardiology AI Direct · 88/100
Both the IRNF App and Withings ECG App are FDA-cleared, over-the-counter tools designed to detect irregular heart rhythms suggestive of Atrial Fibrillation (AFib) using wearable devices. The IRNF…

Related Tools

EchoMD AutoEF
Caption Health (formerly Bay Labs, now part of GE HealthCare)
Cardiology AI
EchoMD AutoEF is an FDA-cleared AI software that automates the selection of echocardiogram clips and calculates left ventricular ejection fraction (EF), enhancing efficiency and accuracy in cardiac assessments.
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm
Anumana, Inc.
Cardiology AI
An AI algorithm for screening cardiac amyloidosis using standard 12-lead ECGs.
DEEPVESSEL Plaque
Keya Medical Technology Co., Ltd.
Cardiology AI
An AI software platform for coronary plaque analysis and quantification from CT angiography.
WatchMate Software
Anumana, Inc.
Cardiology AI
Anumana is an AI-driven health technology company from nference, developing and delivering ECG algorithms enabling early diagnosis and intervention.
syngo.CT Coronary Cockpit
Siemens Healthineers
Cardiology AI
syngo.CT Coronary Cockpit is an AI-powered software tool by Siemens Healthineers for efficient and accurate CT coronary angiography analysis.
HeartLung AI-CVD®
HeartLung Corporation
Cardiology AI
HeartLung AI-CVD® is an FDA-cleared AI-powered quantitative imaging tool that provides automated CT-derived measurements for assessing cardiovascular and multisystem risks opportunistically.

See all Cardiology AI tools →

More from Withings

Withings Scan Monitor
Withings
Cardiology AI
Withings Scan Monitor is an AI-powered tool integrated into smart scales and smartwatches, offering FDA-cleared ECG for AFib detection, heart rate, and other vital health metrics for both personal use and professional remote patient monitoring.
Device purchase with optional subscription for enhanced features and clinical services.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21

Investors who backed Withings ECG App

Funded through the company that built this tool.

Navivo Capital
VC T3
Warsaw, Poland
$1M-$5M
Navivo Capital is an early-stage venture firm with a website and LinkedIn presence consistent with a small European or US emerging manager,…
AI/ML in Healthcare Diagnostics
AI Tool Finder
AI-powered search. Results may not be comprehensive.