Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel)

by Element Science, Inc.  · Based in United States → — Designed to be worn. Designed to save lives.
Cardiology

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Regulatory Status Disclosed

Overview

The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD), developed by Element Science, Inc., is a water-resistant, patch-based wearable defibrillator designed to continuously monitor cardiac rhythms and deliver therapeutic shocks to prevent sudden cardiac arrest (SCA). Utilizing an adhesive-based design and a machine learning algorithm, the device is engineered to minimize motion artifacts and reduce inappropriate shock detections while maintaining continuous protection.

The system is primarily utilized by cardiologists, electrophysiologists, and emergency medicine physicians. It is prescribed for adult patients at elevated risk of SCA who are temporarily ineligible for an implantable cardioverter-defibrillator (ICD), have long-term contraindications to ICD therapy, or are transitioning between device implantations. The care setting spans outpatient home monitoring, transitional care, and hospital environments.

In clinical workflows, the Jewel P-WCD integrates as a temporary therapeutic bridge. It continuously records ECG data and communicates with a dedicated mobile application to assist in patient management. Notable capabilities include:

  • Water-Resistant Design: Allows patients to wear the device continuously, including during showering, to minimize compliance gaps.
  • Machine Learning Detection: Employs advanced algorithms to accurately identify ventricular tachycardia and ventricular fibrillation while mitigating false alarms.
  • Patient-Centric Form Factor: Features a low-profile, adhesive patch design that eliminates the bulky harnesses of traditional wearable defibrillators.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Patch-based wearable cardioverter defibrillator
  • Water-resistant design for continuous wear, including showering
  • Machine learning detection algorithm for arrhythmia detection
  • Continuous heart rhythm monitoring
  • Detects and treats specific life-threatening arrhythmias
  • High patient compliance (median wear time over 23 hours/day)
  • Discreet, under-clothing design
  • Associated Jewel Mobile App for near real-time therapy information to medical team
  • Associated cloud platform (ES Cloud, ES Clinical Portal) for connected care

Use Cases

  • Patients at risk for Sudden Cardiac Arrest (SCA)
  • Patients who are not candidates for or refuse an Implantable Defibrillator
  • Individuals with a temporarily elevated risk for SCA
  • Continuous cardiac protection during normal daily activities, including showering, sleeping, and moderate exercise

What Physicians Need to Know

ECG/EKG Analysis Capability
The Jewel P-WCD continuously monitors ECG signals through adhered electrodes designed to minimize motion artifact. It detects specific life-threatening heart rhythms.
Arrhythmia Detection Accuracy
The device is designed to detect and treat severe arrhythmias, specifically ventricular tachycardia (VT) or ventricular fibrillation (VF). It utilizes a sophisticated machine learning algorithm for accurate detection of abnormal heart rhythms, leading to a low false alarm rate and timely defibrillation. The inappropriate shock rate observed was low, at 0.36 shocks per 100 patient-months.
Cardiac Monitoring Integration
The Jewel Mobile App transmits therapy information to the patient's medical team in near real-time, enabling timely patient care. It provides a streamlined, easy-to-use digital platform for connected care.
AHA/ACC Guideline Alignment
The Jewel P-WCD is intended for patients at temporary risk of sudden cardiac arrest (SCA) where WCD use is recommended by guidelines, such as when clinical improvement is anticipated or a temporary contraindication to an implantable cardioverter-defibrillator (ICD) exists. Clinical data from the Jewel IDE study has been published in the Journal of the American College of Cardiology (JACC).
Real-Time Alert Capability
If a shockable rhythm persists, the Jewel initiates an alarm sequence to alert the patient. The Jewel Mobile App also transmits therapy information to the patient's medical team in near real-time.
Physician Tip

The Jewel P-WCD offers a patient-centric design with high compliance due to its comfort, low-profile, and water-resistant nature, allowing continuous wear during daily activities like showering and sleeping. This continuous monitoring and protection are crucial for patients at temporary elevated risk of sudden cardiac arrest (SCA). The sophisticated machine learning algorithm helps ensure accurate arrhythmia detection and a low rate of inappropriate shocks. Leverage the Jewel Mobile App for near real-time access to therapy information, facilitating timely clinical decision-making and patient management. Consider its use in patients who may not be eligible for or decline an ICD, or during temporary periods of elevated risk.

The Jewel P-WCD integrates with the Jewel Mobile App, which serves as a crucial link for transmitting therapy information to the patient's medical team in near real-time. This digital platform supports connected care, enabling healthcare providers to stay engaged with patient management remotely. Data collected by the device can be analyzed and stored by Element Science.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact vendor — Not publicly available
DeploymentHardware device with associated mobile application and cloud-based digital health platform.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) received U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) P230022 in May 2025. It is indicated for adult patients 18 years of age and older who are at risk for Sudden Cardiac Arrest, and either are not candidates for or refuse an Implantable Defibrillator.

Integrations
EHR Not specified
Specialties Cardiology

What the Web Says

The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) by Element Science is a novel, water-resistant, adhesive-based device designed to provide continuous protection against sudden cardiac arrest (SCA) for patients at temporary high risk. It aims to improve upon traditional wearable cardioverter-defibrillators (WCDs) by enhancing patient comfort and compliance through its low-profile design and machine learning algorithms to minimize inappropriate shocks. Recent studies, including the Jewel IDE Study and EP Lab Study, have shown promising results regarding its safety, effectiveness in converting life-threatening arrhythmias, and high patient wear-time compliance.

Overall: Positive

Strengths

  • High patient compliance with median wear-time over 23 hours per day.
  • Water-resistant design allows for continuous wear during daily activities like showering and moderate exercise.
  • Low inappropriate shock rate (0.36 shocks per 100 patient-months).
  • Effective in converting life-threatening ventricular arrhythmias with a high single-shock success rate (88.9% in one study).
  • Machine learning algorithm designed to minimize inappropriate detections and false alarms.
  • Discreet and comfortable design, addressing common issues with traditional WCDs.

Limitations

  • Clinically significant cutaneous adverse device effects occurred in 2.3% of patients, with 42.6% experiencing some form of skin-related concern (mostly mild rash).
  • Currently an investigational device in the US, limiting its availability.
  • While WCDs may contribute to overall survival benefits, they may not significantly lower the risk of sudden cardiac death itself.
  • The effectiveness of WCDs is closely related to patient compliance.

Based on reviews from: PMC, Element Science, Neuro Central, ClinicalTrials.gov, Cardiac Rhythm News, Sudden Cardiac Arrest Foundation, EP Europace, DAIC, YouTube, Journal of the American College of Cardiology

Last updated: 2026-07-19

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Press & Coverage

FDA
Premarket Approval (PMA) - Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel)
The FDA approved the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel) on April 30, 2025, for adult patients at risk for Sudden Cardiac Arrest who are not candidates for or refuse an Implantable Defibrillator. The approval includes the device, firmware, and associated accessories and software.
2025-04
FDA
Post-Approval Studies (PAS) Database - Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel)
Element Science, Inc. is conducting an ongoing post-approval study for the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), initiated after its approval on April 30, 2025. This study aims to gather further information on the device's continued safety and effectiveness.
2026-07
FDA.report
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel) vs VX1+
The Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) is a water-resistant, patch-based device with a machine learning algorithm for arrhythmia detection and treatment, designed for continuous wear and high patient compliance. It differs from VX1+, which is an AI-powered software for real-time insights during cardiac ablation procedures.
2014-09
FDA.report
Wearable Automated External Defibrillator MVK - Related PMA Records
Several PMA records related to the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel) from Element Science, Inc. are listed, with various supplements and decision dates ranging from August 2025 to March 2026. These records detail updates to the device, firmware, and accessories.
2026-03

Videos

Product demos, reviews, and walkthroughs for Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel).

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Frequently Asked Questions

The Jewel P-WCD utilizes advanced AI algorithms, specifically machine learning, for real-time analysis of cardiac rhythms, aiming to improve the accuracy of arrhythmia detection and reduce inappropriate shocks. This AI-driven approach helps differentiate between benign and life-threatening events, optimizing therapy delivery.
The Jewel P-WCD employs robust encryption protocols and secure data transmission methods to protect patient information, often pairing with a mobile app for real-time data sharing with care teams. While specific details on AI data privacy compliance are not extensively detailed in public summaries, medical devices with AI components are subject to stringent regulatory standards like HIPAA to ensure data privacy and security.
The Jewel P-WCD's AI focuses on continuous learning and personalized rhythm analysis, aiming to minimize inappropriate detections and improve patient compliance due to its comfortable, water-resistant design. While implantable devices have their own advanced algorithms, the Jewel provides a non-invasive, AI-enhanced solution for temporary risk stratification, addressing limitations of traditional, bulkier WCDs.
While advanced AI features contribute to the device's technological sophistication, the overall cost is typically bundled as part of the device. Reimbursement for WCDs generally follows established codes, and specific AI-driven feature billing may depend on evolving payer policies and evidence of improved patient outcomes.
Like all AI systems, the Jewel P-WCD's algorithms may have limitations in detecting rare arrhythmias or in patients with highly unusual ECG morphologies. The device's AI is trained to minimize false alarms and inappropriate shocks, and ongoing post-approval studies are designed to demonstrate the generalizability of its arrhythmia detection algorithm.
The Jewel P-WCD, including its AI-driven algorithms, has received U.S. Food and Drug Administration (FDA) approval, as well as CE mark approval in Europe and UKCA mark approval in the U.K. This approval signifies that the AI components have undergone rigorous regulatory review to ensure safety and efficacy, with post-approval studies planned to further demonstrate the generalizability of its AI/ML algorithm.
The AI in the Jewel P-WCD is designed with machine learning algorithms that learn the patient's own baseline template to identify life-threatening rhythms. This adaptive learning capability allows it to refine its detection parameters based on continuous monitoring of an individual patient's cardiac activity, helping to optimize performance as a patient's condition may change.

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