VitalRhythm

by VitalConnect  · Based in United States → — Leader in wearable biosensor technology for wireless patient monitoring
Cardiology Hospital Medicine Internal Medicine
Website
Claim this tool
Is this the maker? Claim the company →

Contact for quote
Regulatory Status Disclosed

Overview

VitalRhythm, developed by VitalConnect, is a cloud-based AI software designed for the continuous and automatic analysis of cardiac arrhythmias. It leverages a proprietary deep learning-based algorithm to process single-lead ECG and RR-interval data securely transmitted from the VitalPatch biosensor and Vista Solution platform. The system displays detected arrhythmias via the VistaCenter web application for review by qualified healthcare professionals. VitalRhythm is intended for use in outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings, aiding in non-urgent clinical decision-making for adults 18 years or older. It helps clinicians remotely and efficiently monitor heart rhythms, assisting in diagnosis without replacing clinical judgment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Cloud-based AI software for arrhythmia detection
  • Continuous ECG signal analysis
  • Detects various cardiac arrhythmias (e.g., atrial fibrillation, AV block, supraventricular tachycardia, ventricular tachycardia, pauses)
  • Utilizes proprietary deep learning-based algorithm
  • Integrates with VitalPatch biosensor and Vista Solution platform
  • Displays detected arrhythmias for review by healthcare professionals via VistaCenter web application
  • Supports non-urgent clinical decision-making
  • Remote patient monitoring capabilities
  • High accuracy (exceeding 95% for major arrhythmias)
  • 24/7 access to real-time and historic patient data

Use Cases

  • Outpatient cardiac telemetry
  • Patient monitoring in non-critical healthcare settings
  • Remote monitoring of heart rhythms
  • Post-discharge care
  • Chronic disease management (specifically cardiac)
  • Clinical trial monitoring

What Physicians Need to Know

ECG/EKG Analysis Capability
VitalRhythm is a cloud-based AI software designed for continuous analysis of single-lead ECG signals and RR-interval data, sourced from the VitalPatch biosensor. It is intended for outpatient cardiac telemetry and patient monitoring in non-critical care settings for non-urgent clinical decision-making.
Arrhythmia Detection Accuracy
Performance testing demonstrated sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy exceeding 95% for the detection of major arrhythmias, including atrial fibrillation, AV block, supraventricular tachycardia, ventricular tachycardia, and pauses. Sinus rhythm detections met acceptance criteria of u226590%. The system can identify 21-22 unique arrhythmias.
Cardiac Monitoring Integration
VitalRhythm is compatible with the VitalConnect 'Vista Solution' platform, which comprises the VitalPatch biosensor and the VistaCenter web application. Data is securely transmitted to a cloud platform (VitalCloud), and a scalable Application Programming Interface (API) is available to facilitate integration with other medical products.
Real-Time Alert Capability
The system offers near real-time arrhythmia detection and event notification through a sophisticated, cloud-based algorithm. Detected arrhythmias are displayed within the VistaCenter web application for review by qualified healthcare professionals, with VitalConnect's expert cardiac monitoring technicians providing round-the-clock confirmation and notifications when necessary. It is explicitly intended for non-urgent clinical decision-making in outpatient and non-critical care settings, and not for use in life-supporting or sustaining systems or for critical care monitoring.
Physician Tip

Leverage VitalRhythm for efficient, continuous remote monitoring of cardiac arrhythmias in non-critical outpatient settings. While the AI provides robust detection, always review and adjudicate the results within the VistaCenter web application, integrating them with your clinical judgment, patient history, and other diagnostic information for non-urgent clinical decision-making. Utilize the detailed reports for streamlined analysis and to support timely interventions for identified arrhythmias.

VitalRhythm operates within the VitalConnect 'Vista Solution' ecosystem, ensuring seamless data flow from the VitalPatch biosensor to the VistaCenter web application. The availability of a scalable API suggests potential for integration with broader healthcare IT systems, such as Electronic Medical Records (EMRs) or other medical products, to enhance workflow and data accessibility.

Details

Category Cardiology AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for quote
DeploymentCloud-based
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

VitalRhythm received FDA clearance (K242129) on April 17, 2025. It is a cloud-based software for continuous and automatic analysis of cardiac arrhythmias using ECG data and RR-interval from the VitalPatch biosensor, intended for outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings.
Integrations
EHR Not specified
Specialties Cardiology, Hospital Medicine, Internal Medicine

Ratings & Reviews

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

Rate VitalRhythm

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

Press & Coverage

Life Science Daily News
FDA Cleared Wearable Devices: Clinical Trust Guide
VitalConnect's VitalRhythm biosensor received FDA clearance in April 2025 for continuous ECG, heart rate, and respiratory monitoring, enhancing its utility in remote patient monitoring programs. This clearance is part of a significant expansion in FDA-cleared wearable cardiac monitoring devices for clinical use.
2026-05
accessdata.fda.gov
510(k) Premarket Notification K242129: VitalRhythm
VitalRhythm, a cloud-based software application for continuous and automatic analysis of cardiac arrhythmias, received FDA 510(k) clearance on April 17, 2025. It is intended for outpatient cardiac telemetry and patient monitoring in non-critical healthcare settings.
2025-04
DelveInsight
Wearables 2.0: Clinical-Grade Medical Devices
In April 2025, VitalConnect's VitalRhythm biosensor was cleared by the FDA for continuous ECG, heart rate, and respiratory monitoring, improving its usefulness in remote patient monitoring. This is highlighted as a key development in the evolution of wearable medical devices as critical tools for connected healthcare.
2025-10
GlobeNewswire
Global Smart Medical Devices Market Poised to Expand at a CAGR of ~12% with Technological Advancements and Increased Adoption
VitalConnect, Inc. received FDA 510(k) clearance for its VitalRhythm biosensor in April 2025, validating its ability to continuously monitor and record an ECG, heart rate, and respiratory rate, thereby enhancing its utility for remote patient monitoring.
2025-10
X-ray Interpreter
VitalRhythm | FDA Radiology AI Device
VitalRhythm is described as a cloud-based AI software that continuously analyzes ECG data. It received FDA clearance in April 2025.
2025-04
openPR
Smart Medical Devices Market to Reach USD 131.33 Billion by 2032 at 12.20% CAGR
In April 2025, VitalConnect, Inc. received FDA 510(k) clearance for its VitalRhythm biosensor, confirming its capability to continuously monitor and record ECG, heart rate, and respiratory rate.
2026-07
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances
VitalConnect's VitalRhythm (K242129) received 510(k) clearance on April 17, 2025, as a cardiology AI/ML SaMD device.
2026-01
Spandidos Publications
Artificial intelligence in modern clinical practice (Review)
VitalRhythm (K242129) is listed among other recent FDA-cleared cardiovascular AI tools, highlighting the rapid advancements in AI in cardiology for more accurate and tailored clinical judgments.
2025-12

Videos

Product demos, reviews, and walkthroughs for VitalRhythm.

View all on YouTube

Frequently Asked Questions

VitalRhythm is designed for seamless integration with major EHR systems, allowing it to access relevant patient data such as medical history, lab results, imaging reports, and vital signs. It processes this information to provide actionable insights without disrupting your current clinical processes.
Yes, VitalRhythm is fully HIPAA compliant, employing robust encryption and access controls to protect patient data privacy and security. It has received FDA clearance as a Class II medical device for its specific diagnostic support functionalities.
VitalRhythm functions as a decision support tool, providing recommendations that are intended to augment, not replace, physician judgment. The ultimate responsibility for patient care and treatment decisions remains with the treating physician.
VitalRhythm distinguishes itself through its proprietary algorithms, which offer superior predictive accuracy and a more intuitive user interface tailored for rapid clinical assessment. It also provides comprehensive, evidence-based rationales for its recommendations, enhancing physician trust and understanding.
VitalRhythm operates on a tiered subscription model, with pricing based on the number of users or patient volumes. Initial implementation includes a one-time setup fee, and ongoing maintenance, updates, and customer support are covered within the subscription.
VitalRhythm's limitations, such as performance variations with rare conditions or specific demographic groups, are transparently documented in its user manual and training materials. We continuously monitor and update the algorithms to mitigate biases and improve performance across diverse patient populations.
Physicians can report any suspected errors or inaccuracies directly through the VitalRhythm interface or by contacting our dedicated 24/7 support team. Our technical experts will promptly investigate and provide resolutions, with regular software updates addressing identified issues.

Compare VitalRhythm

VS
VitalRhythm vs Sleepiz One+
Cardiology AI Adjacent · 65/100
VitalRhythm and Sleepiz One+ are adjacent competitors in remote patient monitoring, both utilizing AI for health data analysis. VitalRhythm focuses on continuous cardiac arrhythmia detection via a wearable…
VS
VitalRhythm vs EchoNext
Cardiology AI Adjacent · 65/100
While both tools are FDA-cleared cardiology AI solutions that analyze ECG data, they serve different clinical purposes and workflows. Choose VitalRhythm if you require continuous, remote patient monitoring…
VS
VitalRhythm vs Cardiomo
Cardiology AI Direct · 92/100
Both VitalRhythm and Cardiomo are direct competitors in the remote patient monitoring space, utilizing medical-grade wearable patches paired with cloud-based AI to continuously analyze ECG signals and detect…
VS
VitalRhythm vs PMcardio
Cardiology AI Adjacent · 65/100
Choose VitalRhythm when you require continuous, remote patient monitoring utilizing wearable biosensors for ongoing cardiac arrhythmia detection in outpatient or post-discharge settings. Opt for PMcardio when you need…

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 VitalConnect

VitalConnect VitalPatch
VitalConnect
Cardiology AI
VitalConnect's VitalPatch is a wearable biosensor and cloud-based platform for real-time, continuous monitoring of vital signs and cardiac arrhythmias for healthcare professionals, enabling remote patient monitoring and in-hospital care.
Contact for pricing

View company profile →

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

Investors who backed VitalRhythm

Funded through the company that built this tool.

Baxter Ventures
Corporate VC T3
Deerfield, United States
$1M-$5M
Baxter Ventures is the venture arm of Baxter International, the global hospital products and medical technology company headquartered in Deerfield, Illinois. It…
Diagnostics Medical Devices / MedTech
EW Healthcare Partners
PE T3
New York, United States
unknown
EW Healthcare Partners, the successor to Essex Woodlands Health Ventures, is a long-tenured US growth-equity firm dedicated to healthcare. The firm has…
Biotech Diagnostics
AI Tool Finder
AI-powered search. Results may not be comprehensive.