VitalRhythm
by VitalConnect
· Based in United States →
— Leader in wearable biosensor technology for wireless patient monitoring
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 |
| Deployment | Cloud-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
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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.
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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.
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| Last Verified: 2026-04-19 | First Added: 2026-04-19
Investors who backed VitalRhythm
Funded through the company that built this tool.
