Rooti Rx ECG Event Recorder

by Rooti Labs Ltd.  · Based in Taiwan → — AI-Powered Wearable ECG for Rapid and Accurate Cardiac Diagnosis
Cardiology Family Medicine Internal Medicine

Contact for pricing
Regulatory Status Disclosed

Overview

The Rooti Rx ECG Event Recorder is a compact, wearable physiological recording module designed for continuous and remote capture of single-lead or three-channel electrocardiography (ECG) signals. Paired with the RootiCare System and the Rooti Link mobile application, it offers an intelligent monitoring solution that abstracts clinical-grade biometrics from ECG signals and utilizes deep learning for insights derived from thousands of clinical cases.

The device is worn non-obtrusively on the chest, eliminating the complexity and discomfort associated with traditional medical equipment. Its lightweight (14 grams) and waterproof (IP58) design allows patients to maintain their normal quality of life while recording authentic physiological signals for up to 7 days.

The RootiCare platform provides online ECG review and editing, generating comprehensive reports for medical institutions in less than 24 hours, enhanced by precise AI interpretation and quality assurance checks. This significantly accelerates diagnostic and treatment processes for physicians.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Compact wearable ECG device (single or three-channel options)
  • Up to 7-day ECG and actigraphy recording
  • 24-bit high-resolution ECG images
  • Mobile telemetry cardiac tags for real-time event marking
  • AI-driven interpretation and quality assurance checks
  • Online ECG review and editing via RootiCare platform
  • Fast report generation within 24 hours
  • Wi-Fi upload of data to RootiCare database
  • Lightweight (14 grams) and waterproof (IP58) design
  • Preview mode for signal check prior to recording

Use Cases

  • Long-term monitoring for abnormal heart rhythms, such as atrial fibrillation
  • Diagnosis of cardiovascular and pulmonary conditions
  • Assessment of sleep apnea
  • Screening for potential diseases like insomnia, hypertension, or arrhythmia
  • Remote patient monitoring in home or workplace settings
  • Medical research for precise data collection and correlation discovery

What Physicians Need to Know

ECG/EKG Analysis Capability
The Rooti Rx system provides 7-day ECG and actigraphy recording with 24-bit high-resolution ECG images. It offers options for single or three-channel ECG recording. The RootiCare platform abstracts clinical-grade biometrics from ECG signals using deep learning and generates comprehensive reports within 24 hours, utilizing precise AI interpretation and quality assurance checks. A preview mode allows doctors to verify signal quality before recording.
Arrhythmia Detection Accuracy
The device aids in identifying conditions such as arrhythmias and is designed for long-term monitoring of abnormal heart rhythms, including atrial fibrillation and pre-stroke indicators. The RootiCare platform leverages deep learning from thousands of clinical cases to assist in screening for arrhythmias. A study on a similar Rooti Labs device (BeyondCareu00ae Patch) demonstrated a 98% average beat per minute correlation with standard 12-lead Holter monitors and a 93.6% mean analyzable wear time, suggesting improved clinical accuracy in arrhythmia detection through its cloud-based AI system. Event recorders generally show higher diagnostic yields for arrhythmias compared to traditional Holter monitors.
Cardiac Monitoring Integration
Rooti Rx is a wearable device that continuously and remotely captures ECG signals. It features built-in Wi-Fi for direct upload of recordings to the RootiCare database. The Rooti Rx app provides a secure, FDA-registered interface for medical professionals to initialize and manage the device. It integrates with the RootiCare intelligent monitoring platform for data analysis and report generation and can be utilized for Holter monitoring services. Additionally, Rooti Kiosk, which incorporates Rooti Rx technology, enables instant onsite ECG measurement and rapid analysis.
Real-Time Alert Capability
The Rooti Rx provides a real-time event tag feature, allowing patients to manually or automatically mark the occurrence time of symptoms or discomfort by pressing a button on the device. This enables physicians to correlate symptoms with recorded heart rhythms for accurate interpretation. While the device records continuously in the background, the Rooti Rx app displays real-time ECG waveforms and heart rate during device setup; however, the app itself does not analyze patient medical conditions or provide real-time diagnostic analysis or medical advice. Data is stored on the device and uploaded for analysis rather than being a live feed for immediate physician review.
Physician Tip

Leverage the 7-day, 24-bit high-resolution ECG recording for detailed examination of cardiac events and precise diagnoses, particularly for conditions like atrial fibrillation. Utilize the patient-activated event tagging feature to effectively correlate reported symptoms with recorded ECG data, providing a comprehensive view of cardiac events. Maximize the efficiency of the RootiCare platform's AI interpretation and online review/editing capabilities for prompt and accurate report generation. Consider the single or three-channel options based on the specific diagnostic needs, noting that three channels offer enhanced accuracy through cross-verification. Employ the preview mode to ensure optimal signal quality before initiating prolonged monitoring, thereby minimizing invalid recordings.

The Rooti Rx device seamlessly integrates with the RootiCare intelligent monitoring platform, which facilitates data abstraction, deep learning-based insights, and the generation of comprehensive reports. Data upload from the device to the platform is enabled via built-in Wi-Fi. Medical professionals use the Rooti Rx app as a secure, FDA-registered interface for device initialization and management. Furthermore, Rooti Kiosk offers an integrated solution for onsite ECG measurement and rapid analysis, leveraging Rooti Rx technology.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing — Custom pricing available upon request
DeploymentCloud-based (RootiCare platform on AWS) and device-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Rooti Rx System ECG Event Recorder, along with the Rooti Link APP Software, received 510(k) clearance (K163694) from the FDA on November 7, 2017. It is intended for recording single-lead electrocardiography (ECG) data for post-analysis by medical professionals and is indicated for use on general care patients aged 21 years or older, not for critical care patients.

Integrations
EHR Not specified
Specialties Cardiology, Family Medicine, Internal Medicine

What the Web Says

The Rooti Rx ECG Event Recorder is a wearable, single-lead (with options for three-channel) ECG recording device designed for long-term cardiac monitoring in general care patients aged 21 and older. It aims to provide a comfortable and less intrusive alternative to traditional Holter monitors, allowing patients to maintain normal daily activities while recording ECG data. The device stores data locally and transmits it via Wi-Fi to medical professionals' iOS devices for analysis, with reports generated within 24 hours through the RootiCare platform, which utilizes AI interpretation.

Overall: Positive

Strengths

  • Comfortable and non-obtrusive wearable design, allowing for normal daily activities.
  • Extended monitoring capabilities (up to 7 days), increasing the chance of detecting infrequent arrhythmias.
  • High-resolution 24-bit ECG recording for precise examination of cardiac events.
  • Real-time event tagging for patients to mark symptoms, aiding in accurate interpretation.
  • Fast report generation (within 24 hours) with AI interpretation and quality assurance checks.
  • Waterproof and lightweight design.

Limitations

  • Primarily single-lead ECG recording, which may offer less comprehensive data than multi-lead systems for certain diagnostic purposes.
  • The Rooti Rx app is for medical professionals only and solely for device setup; it does not analyze patient conditions or display results to patients.
  • Not intended for critical care patients.
  • Limited information available from independent tech reviewers, G2, Capterra, or extensive Reddit discussions specifically on Rooti Rx.
  • Potential for skin irritation from adhesives, as noted with similar wearable monitors.

Based on reviews from: Rooti Labs Ltd. (FDA Radiology AI Device), Rooti Care (rootilabs.com), The heart monitoring technology that meets the highest standard - Rooti Care (rootilabs.com), Rooti Rx System ECG Event Recorder-Refront IoMT Corp., Rooti Rx - App Store - Apple, accessdata.fda.gov, Holter Monitoring with RootiRx and RootiCare. - Satellite Echo Services, Rootirx | Ninkatec, A simple patch to a simpler life - Rooti Labs, What is a holter monitor? - Flow Health & Cardiac Diagnostics, Reddit (r/Cardiology, r/POTS, r/ehlersdanlos), Choosing between ECG monitoring devicesu2013Holter or no Holter, that's the question (YouTube), Portable outu2010ofu2010hospital electrocardiography: A review of current technologies - PMC, Cardiologist's Review of Heart Monitors - Natural Heart Doctor, Wearable Electrocardiogram Technology: Help or Hindrance to the Modern Doctor? - PMC, Remote Cardiac Rhythm Monitoring in the Era of Smart Wearables: Present Assets and Future Perspectives - PMC, Top 3 Best ECG Monitors in 2025 - YouTube

Last updated: 2026-07-18

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Press & Coverage

RadAI Slice
Rooti Rx ECG Event Recorder, Rooti Link APP Software | FDA Radiology AI Device
The Rooti Rx System is a wearable single-lead ECG recording device that allows patients to record ECG data at home or work, transmitting it via Wi-Fi to medical professionals' iOS devices for post-analysis. It received FDA 510(k) clearance on November 7, 2017, for patients 21 years or older.
2017-11
FDA
K163694 - 510(k) Premarket Notification - FDA
This document is the official FDA 510(k) Premarket Notification for the Rooti Rx ECG Event Recorder and Rooti Link APP Software, submitted by Rooti Labs Ltd. It details the device's intended use, technology, and performance, demonstrating substantial equivalence to a predicate device.
2017-11
Innolitics
DRG u00b7 Transmitters And Receivers, Physiological Signal, Radiofrequency u2014 FDA Product Code | Innolitics
This entry lists the Rooti Rx ECG Event Recorder, Rooti Link APP Software under FDA product code DRG, indicating its clearance on November 7, 2017. DRG refers to radiofrequency physiological signal transmitters and receivers used for conditioning and transmitting physiological signals.
2017-11
ResearchGate
Digital Health Trends 2024 - ResearchGate
The Rooti Labs Rooti Rx ECG Event Recorder, Rooti Link APP Software is mentioned in this report as a digital diagnostic tool for cardiovascular monitoring. The report examines trends across various segments of the digital health market, including digital diagnostics and wearable sensors.
2024-12
Physician AI Tools
Rooti Rx ECG Event Recorder vs syngo.CT CaScoring - Medical AI Tools for Physicians
This comparison highlights Rooti Rx as an AI-powered wearable ECG for continuous cardiac monitoring and event detection, offering up to 7 days of recording with AI-driven interpretation. It emphasizes Rooti Rx's clinical evidence from over 35 peer-reviewed publications.
unknown
Scribd
Digital Health Trends 2024 Report | PDF | Medical Diagnosis - Scribd
The Rooti Labs Rooti Rx ECG Event Recorder, Rooti Link APP Software is listed among various digital health solutions for vitals monitoring in this comprehensive report on digital health trends. It notes the device's role in remote patient monitoring.
2024-12
ResearchGate
(PDF) Digital Health Trends 2024 Implications for Research and Patient Care
This report includes Rooti Labs Rooti Rx ECG Event Recorder, Rooti Link APP Software in its discussion of AI/ML-enabled medical devices for cardiac monitoring platforms. It highlights the expanding number of approval and reimbursement pathways for new digital health products.
2023-10
Physician AI Tools
CINA CHEST vs Rooti Rx ECG Event Recorder - Physician Ai Tools
This article compares Rooti Rx ECG Event Recorder with CINA CHEST, emphasizing Rooti Rx's innovation in combining a compact, wearable ECG device for continuous cardiac monitoring with an AI-powered platform for rapid diagnosis and real-time event marking.
unknown

Videos

Product demos, reviews, and walkthroughs for Rooti Rx ECG Event Recorder.

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Frequently Asked Questions

The Rooti Rx system, through its RootiCare cloud analytics, utilizes deep learning and AI to provide faster and more accurate report analysis, abstracting clinical-grade biometrics from ECG signals. It is designed to assist in the diagnosis of conditions like atrial fibrillation (AFib) and can also be used for the assessment of sleep apnea by combining ECG with chest wall motion and heart rate variations.
The Rooti Rx System is CE certified under the European Union's Medical Device Regulation (EU) 2017/745 for the exclusive indication of ECG recording and analysis. In the U.S., it has FDA 510(k) clearance for patients aged 21 or older to record single-lead ECG data for post-analysis by medical professionals.
While AI in ECG analysis offers promising results, general limitations include concerns about professional liability, systematic bias, cybersecurity, and the need for algorithms to be validated for specific patient populations. It's important to note that the Rooti Rx app itself is for device setup and management, not for analyzing patient medical data, and the EU certification for RootiCare is exclusively for ECG recording and analysis, with other uses not evaluated.
The Rooti Rx offers 7-day ECG and actigraphy recording in a compact, wearable, and waterproof design, providing comprehensive physiological data. Unlike traditional Holter monitors with shorter recording durations, Rooti Rx, combined with RootiCare's AI, aims for faster report delivery (within 24 hours) and enhanced accuracy through deep learning.
Specific pricing details for the Rooti Rx system are not publicly available and are typically obtained directly from Rooti Labs. Medical device pricing often involves a combination of upfront costs for the hardware and recurring service fees for data analysis, AI interpretation, and report generation through platforms like RootiCare.
Rooti Labs emphasizes compliance with global regulations such as GDPR, prioritizing the protection of individual rights and data portability. The RootiCare system is designed to be secure and compliant, utilizing robust measures to safeguard patient information from unauthorized access and ensuring confidentiality and integrity through encrypted access for reports.
Yes, the RootiCare system is designed to integrate with hospital EMR systems, creating a streamlined and efficient reporting process. This integration allows physicians maximum flexibility to review and edit AI-generated reports online, enhancing accuracy and accelerating diagnostic and treatment processes by providing timely data.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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