ASSURE Wearable ECG

by Kestra Medical Technologies  · Based in United States → — Innovative, intuitive, and mobile diagnostic and therapeutic technologies for cardiac patients.
Cardiology
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Overview

The ASSURE Wearable Cardioverter Defibrillator (WCD) System by Kestra Medical Technologies is a prescription-based, patient-worn cardiac recovery system designed to protect individuals at risk of sudden cardiac arrest (SCA). The system continuously monitors the patient’s electrocardiogram (ECG) to autonomously detect life-threatening ventricular arrhythmias, such as ventricular tachycardia and ventricular fibrillation, and delivers defibrillation therapy to restore normal heart rhythm without requiring bystander intervention.

The system is indicated for adult patients who are at elevated risk for SCA but are not immediate candidates for, or have refused, an implantable cardioverter defibrillator (ICD). This includes individuals recovering from myocardial infarction, those undergoing coronary revascularization, or patients newly diagnosed with heart failure exhibiting a low left ventricular ejection fraction (LVEF of 35% or below). It is utilized across cardiology, electrophysiology, and heart failure clinics, as well as outpatient cardiac rehabilitation settings.

In terms of clinical workflow, the ASSURE system integrates into practice via the Kestra CareStation remote data platform. This platform transmits recorded ECG data, heart rate histograms, and patient-triggered episode reports directly to the prescribing clinical team. This connectivity supports clinical decision-making and guideline-directed medical therapy (GDMT) optimization during the critical early phases of cardiac recovery.

  • Autonomous Detection & Therapy: Automatically analyzes cardiac rhythms and delivers targeted defibrillation shocks.
  • CareStation Remote Platform: Provides clinicians with remote access to patient compliance data, trended physiological metrics, and recorded arrhythmia episodes.
  • Tailored Garment Design: Features a lightweight, discreet garment designed to accommodate diverse patient anatomies, including specific design considerations for female patients.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Wearable ECG device for continuous heart rate monitoring
  • SensorFit Garment with non-adhesive, embedded, and cushioned ECG sensors
  • ASSURE Detection Algorithm with Quad Channel Processingu2122
  • Adaptive Patient Intelligenceu2122 for filtering motion artifacts
  • Automatic episode storage
  • Alert-based notifications
  • Physiologic trend data
  • Kestra CareStation remote patient data platform for clinician review
  • ASSURE Patient App for patient monitoring and data transmission
  • ASSURE Assist service for post-event support activation

Use Cases

  • Continuous heart rate monitoring for adult patients
  • Continued evaluation of heart rates and rhythms for patients post-WCD use
  • Remote patient monitoring and data analysis for healthcare providers
  • Supporting patient recovery after cardiac events

What Physicians Need to Know

ECG/EKG Analysis Capability
The ASSURE Wearable ECG utilizes Quad Channel Processingu2122 with four channels of high-fidelity ECG, requiring only one noise-free channel for rhythm analysis. Its Adaptive Patient Intelligenceu2122 technology filters out artifacts caused by patient motion. The system analyzes heart rhythms and stores automatic episode data along with physiologic trend data. It generates clear patient reports detailing ventricular tachycardia (VT), ventricular fibrillation (VF), supraventricular tachycardias (SVTs), bradycardia, asystole, patient-triggered episodes, and non-sustained ventricular arrhythmia episodes.
Arrhythmia Detection Accuracy
The ASSURE Detection Algorithm is designed to detect various arrhythmias, including life-threatening ventricular arrhythmias (VT/VF), high-rate atrial fibrillation, and severe bradycardia/asystole. In real-world use, the system detected arrhythmias in 18% of patients, leading to physician-directed clinical intervention, including VT/VF in 7% and SVTs (including AF/AFL) in 11%. It also identified previously undiagnosed atrial fibrillation in 5.5% of patients with high stroke risk and recorded asymptomatic VT in 3.6% of patients. Studies have shown high sensitivity for VF (99.0%) and VT (98.4%) with the underlying detection algorithm, and the system is designed to minimize false alarms, with up to 87% fewer false alarms than competing devices and 94% of patients experiencing no false positive shock alarms.
Heart Failure Risk Prediction
While not a direct heart failure risk prediction tool, the ASSURE Wearable ECG monitors for arrhythmias relevant to heart failure management and risk stratification, particularly in patients at risk for sudden cardiac arrest, including those with low ejection fraction. Future integration with Biobeat's ambulatory blood pressure monitoring (ABPM) technology aims to expand diagnostic insights for patients, especially those with hypertension, which is crucial for managing cardiac recovery and optimizing guideline-directed medical therapy.
Cardiac Monitoring Integration
The device seamlessly integrates with the Kestra CareStation remote patient data platform, where all automatic episode storage, alert-based notifications, and physiologic trend data are uploaded. The ASSURE Patient App securely transmits heart rhythm data and allows patients to monitor their usage time and activity. The Kestra CareStation provides configurable notifications for clinical events and offers clear patient reports, including arrhythmia types, device usage, physical activity trends, and heart rate trends. Kestra's Heart Alertu2122 Services identify and notify providers of cardiac events that may warrant action, and the ASSURE Assist service provides post-event support.
AHA/ACC Guideline Alignment
The ASSURE detection algorithm's performance meets or exceeds the American Heart Association (AHA) recommendations as required by IEC 60601-2-4. The ASSURE system, including the WCD, has received FDA PMA approval. Results from the ACE-PAS study, the largest prospective real-world study of wearable defibrillators, are expected to inform future updates to clinical practice guidelines, particularly concerning the identification and protection of patients at early risk of sudden cardiac death.
Real-Time Alert Capability
The ASSURE Wearable ECG provides alert-based notifications and real-time monitoring capabilities. The Heart Alertu2122 Services actively identify and notify healthcare providers of cardiac events that may require intervention. For the therapeutic ASSURE WCD (which shares the same detection algorithm), the system issues alerts to the patient upon arrhythmia detection, providing an opportunity to divert a shock if conscious.
Physician Tip

For patients transitioning from the ASSURE WCD or those requiring continuous cardiac monitoring, the ASSURE Wearable ECG offers robust, multi-channel ECG analysis with advanced artifact filtering for reliable rhythm interpretation. Leverage the Kestra CareStation for comprehensive patient data, including detailed arrhythmia reports and physiological trends, to inform clinical decision-making and optimize guideline-directed medical therapy. The real-time alert system and integrated patient app facilitate timely intervention and patient engagement in their recovery. Consider the insights from the ACE-PAS study regarding arrhythmia detection and patient compliance when evaluating its use for at-risk populations.

The ASSURE Wearable ECG integrates seamlessly with the Kestra CareStation remote patient data platform and the ASSURE Patient App for secure data transmission and comprehensive monitoring. Kestra Medical Technologies is actively collaborating with Biobeat Technologies to integrate ambulatory blood pressure monitoring (ABPM) data into its product portfolio, which will further enhance diagnostic insights, especially for hypertensive cardiac recovery patients. The system is designed to provide a connected digital healthcare experience, supporting both patient engagement and provider oversight.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing. — Contact for pricing.
DeploymentWearable device, mobile application, and cloud-based remote patient data platform.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Kestra Medical Technologies, Inc. received FDA clearance (K233864) for the ASSURE Wearable ECG device on May 7, 2024. It is classified under 21 CFR 870.2800 as a Class II medical device, intended for continuous heart rate monitoring in adult patients prescribed by a medical professional, without providing diagnostic interpretations or therapies.
Integrations
EHR Not specified
Specialties Cardiology

What the Web Says

The Kestra Medical ASSURE Wearable ECG (Wearable Cardioverter Defibrillator - WCD) system is designed for adult patients at risk of sudden cardiac arrest who are not candidates for or refuse an implantable defibrillator. It continuously monitors ECG, detects life-threatening ventricular arrhythmias (VT/VF), and can automatically deliver a defibrillating shock. The system has received FDA approval and has shown strong effectiveness and safety in clinical studies, with high patient compliance and low false alarm rates.

Overall: Positive

Strengths

  • High patient compliance and wear time, with patients wearing the device for a median of over 23 hours per day.
  • 100% successful conversion rate for ventricular tachycardia and fibrillation (VT/VF) events.
  • Low inappropriate shock rate and minimal false positive shock alarms (94% of patients experienced no false positive shock alarms).
  • User-friendly and more comfortable by design compared to previous wearable defibrillators.
  • Provides additional ECG and heart failure data, enabling remote monitoring and detection of other clinically relevant arrhythmias like high-rate atrial fibrillation and severe bradycardia/asystole.
  • Intuitive technology that works with a cell phone for easy understanding.

Limitations

  • Some reports of aggressive sales tactics and billing issues from Kestra Medical Technologies, including harassing phone calls and incorrect balances.
  • Potential for skin irritation (19.4%) and musculoskeletal discomfort (8.5%) as adverse events.
  • Contraindicated for patients with an active implantable defibrillator.
  • Operating noisy or vibrating vehicles/equipment while wearing the system may prevent the patient from realizing an alert.
  • Not intended for use on patients with an implantable pacemaker that produces a pacemaker pulse artifact greater than 0.5 mV on any ECG channel, as this may interfere with detection and shock delivery.

Based on reviews from: PMC (PubMed Central), Kestra Medical Technologies (Provider Viewpoints), HRX 2023: ASSURE Clinician Experience (ACE) w/ Kestra Medical, Largest Real-World Study of Wearable Defibrillators Confirms Strong Effectiveness and Safety Performance of Kestra's ASSURE Device, A wearable cardioverter defibrillator with a low false alarm rate - PMC - NIH, International Hospital, Nasdaq, accessdata.fda.gov, Quiver Quantitative, Better Business Bureau (BBB)

Last updated: 2026-07-19

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Press & Coverage

Business Wire via Kestra Medical Technologies
Kestra Medical Technologies Announces $196 Million Oversubscribed Financing Round
Kestra Medical Technologies secured $196 million in an oversubscribed funding round to expand its commercial organization and advance its mission of protecting at-risk patients with its Wearable Cardioverter Defibrillator (WCD) system, which includes the recently FDA-cleared ASSURE Wearable ECG. The funding will support the commercial expansion and advancement of the WCD system.
2024-07
Medical Device Network
Kestra secures $196m to boost ASSURE system commercialisation
Kestra Medical Technologies has secured $196 million in funding to accelerate the commercialization of its ASSURE WCD system, which includes the ASSURE Wearable ECG. The ASSURE system is designed for autonomous detection and defibrillation for ventricular arrhythmias and records other significant arrhythmias.
2024-07
Medical Device Developments
Kestra secures $196m funding to expand its WCD portfolio
Kestra Medical Technologies has raised $196 million in an oversubscribed funding round to expand its commercial reach and advance its Wearable Cardioverter Defibrillator (WCD) technology, which includes the FDA-approved ASSURE Wearable ECG. The system provides autonomous detection and defibrillation for ventricular arrhythmias and records other clinically significant arrhythmias.
2024-07
FDA
510(k) Premarket Notification - K233864 ASSURE Wearable ECG
The FDA granted 510(k) clearance for the ASSURE Wearable ECG on May 7, 2024. This device is intended for continuous heart rate monitoring in adult patients who were previously prescribed the ASSURE WCD system and may experience transient cardiac symptoms.
2024-05
Orthogonal
Bluetooth Medical Devices Cleared by FDA in 2024
Kestra Medical Technologies received 510(k) clearance for its ASSURE Wearable ECG in 2024. This continuous cardiac monitoring device transmits ECG data via Bluetooth Low Energy to a mobile app, allowing real-time, wireless monitoring and remote access for healthcare providers.
2025-01
Scribd (IQVIA Institute)
Digital Health Trends 2024 Report
The ASSURE Wearable ECG from Kestra Medical Technologies is highlighted in a Digital Health Trends 2024 report as a sensor-based digital measure. The report discusses the evolving landscape of digital health, including consumer apps, digital therapeutics, and sensor-based monitoring tools.
2024-12
ResearchGate
Artificial Intelligence and Machine Learning in Software as a Medical Device (SaMD)
The ASSURE Wearable ECG system, approved by the FDA in May 2024, utilizes artificial intelligence in its algorithms, specifically Adaptive Patient Intelligence, to filter out noise and improve accuracy. This is noted in a discussion about the role of AI and Machine Learning in Software as a Medical Device (SaMD).
2025-05
Stock Titan
Kestra Medical (NASDAQ: KMTS) targets $24B wearable defibrillator market
Kestra Medical Technologies recently launched its ASSURE Wearable ECG to expand into providing monitoring and connectivity solutions for patients who no longer require a WCD but still need ongoing cardiac support. The company's Cardiac Recovery System platform, anchored by the ASSURE WCD, has protected nearly 40,000 patients as of April 30, 2026.
2026-07

Videos

Product demos, reviews, and walkthroughs for ASSURE Wearable ECG.

View all on YouTube

Frequently Asked Questions

The AI in ASSURE Wearable ECG continuously analyzes ECG data to detect and classify arrhythmias, providing physicians with actionable insights and trends for proactive patient management. It aims to reduce the burden of manual review by highlighting clinically significant events and physiological trend data.
The ASSURE Wearable ECG, including its AI algorithm, received FDA approval in May 2024. Patient data privacy is secured through robust encryption protocols, consent management, anonymization, and adherence to HIPAA/GDPR compliance standards, with data processed and stored securely on platforms like Kestra CareStation.
ASSURE Wearable ECG offers continuous, long-term monitoring with real-time AI analysis, which can identify transient events that might be missed by shorter-term Holter recordings. Its AI, featuring Quad Channel Processing and Adaptive Patient Intelligence, is designed to reduce noise and provide clear data, offering enhanced accuracy and automated reporting compared to traditional Holter monitors that rely on retrospective manual interpretation.
While specific pricing details are not publicly available, the ASSURE system is backed by reimbursement and broad insurance coverage in the US for its Wearable Cardioverter Defibrillator (WCD) component. The pricing model typically involves the device, AI analysis, and secure cloud data storage via the Kestra CareStation platform.
The ASSURE Wearable ECG system is designed to minimize false alarms, with studies on the ASSURE WCD showing a low false-positive shock alarm rate. However, like many wearable ECG algorithms, it may have limitations in distinguishing certain arrhythmias or in cases with significant noise artifact from patient motion. It is contraindicated for patients with active implantable pacemakers or defibrillators if the pacemaker pulse artifact is too large.
The AI-generated reports from ASSURE Wearable ECG are designed for integration with major EHR systems, allowing clinicians to access patient data and insights into heart rhythms, trends, and patient compliance via the Kestra CareStation data platform. This streamlines the review process, providing concise summaries and full ECG strips through a secure portal.
The AI algorithm in the ASSURE system undergoes continuous validation through real-world data and studies, such as the ACE-PAS study which confirmed its safety and effectiveness. Updates are periodically deployed to enhance accuracy and detection capabilities, ensuring the system evolves with clinical needs and new evidence, aligning with FDA's goals for regulating AI/ML-based Software as a Medical Device.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18

Investors who backed ASSURE Wearable ECG

Funded through the company that built this tool.

Longitude Capital
VC T3
Menlo Park, United States
$25M+
Longitude Capital is an established healthcare-dedicated venture firm investing across biotechnology and medical technology, with offices on both coasts and a long…
Biotech Care Delivery / Tech-Enabled Services
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