Symptoms may not reveal early dysfunction
Fatigue, shortness of breath, and reduced exercise tolerance can be subtle, intermittent, or attributed to other conditions.
AiTiA LVSD Silent Mode Study
Medical AI - AI Powered ECG
Clinical Research Opportunity
IN COLLABORATION WITH MEDICAL AI
AiTiA LVSD
Silent Mode Study
AI-powered ECG analysis supporting earlier identification of left ventricular systolic dysfunction.
CGM is introducing qualified healthcare organizations to the AiTiA LVSD Silent Mode Study. Developed by Medical AI, AiTiA LVSD analyzes subtle electrical patterns within a standard 12-lead ECG to help identify patients who may have left ventricular systolic dysfunction.
Utilizing a simple IRB-approved protocol that does not disrupt normal clinical workflow, participating sites contribute to real-world clinical validation while continuing their existing ECG workflow and standard of care. AI-generated analyses remain hidden from clinicians and are not used for patient-care decisions during the study.
Participating sites receive
all required equipment, software, installation, training, and technical support at no cost throughout the Silent Mode Study. Research-support compensation is governed by the executed agreement.
Silent Mode Research
Clinical validation without disrupting physician workflow.
Why Participate
Help shape the future of ECG intelligence.
The Silent Mode Study evaluates AiTiA LVSD in real-world clinical environments where standard 12-lead ECGs are already part of care. Participation allows organizations to contribute research data without altering the established clinical workflow or standard of care.
Within the separate research environment, AiTiA LVSD captures and analyzes data from qualifying ECGs. The study data support Medical AI’s evaluation of algorithm performance, real-world workflow integration, and the ongoing regulatory review process. CGM works with qualified organizations to assess study fit, coordinate participation, and support implementation planning.
During Silent Mode, AiTiA LVSD operates for research purposes only. Its analyses are not available for diagnosis, treatment decisions, or patient management.
The Clinical Opportunity
Heart failure can advance before the signs are obvious.
Left ventricular systolic dysfunction may develop gradually and remain unrecognized until symptoms become more pronounced. AiTiA LVSD is designed to identify ECG patterns associated with possible LVSD so physicians can determine when echocardiography or further cardiovascular evaluation may be appropriate.
Confirmation requires additional testing
A conventional ECG does not diagnose LVSD, while echocardiography requires added time, scheduling, and clinical resources.
Earlier risk identification can guide follow-up
AiTiA LVSD is designed to help physicians identify patients who may benefit from echocardiography or further cardiovascular evaluation.
Beyond the Visible Tracing
A deeper analysis of the ECG already being performed.
AiTiA LVSD analyzes approximately 60,000 numerical data points captured during a standard 10-second, 12-lead ECG. It evaluates subtle electrical patterns associated with possible left ventricular systolic dysfunction, including heart failure with reduced ejection fraction.
While conventional interpretation focuses on the visible tracing, AiTiA LVSD examines the underlying numerical data to provide an additional risk-assessment layer. Diagnosis, treatment, and follow-up decisions remain with the physician.
The Same Familiar ECG
No additional electrodes, blood draw, radiation, specialized appointment, or separate patient procedure is required.
Analysis in Seconds
The platform is designed to analyze the ECG rapidly and generate a 0–100 severity score with a corresponding risk classification.
Insight That Supports the Physician
A higher-risk result may help physicians identify patients who should be considered for echocardiography or additional cardiovascular evaluation.
Designed for Existing Systems
AiTiA LVSD is designed for integration with compatible ECG devices, ECG management systems, and EMR/PACS environments without adding steps to ECG acquisition.
Clinical Evidence
Demonstrated performance across clinical studies.
AiTiA LVSD has been evaluated in peer-reviewed studies across multiple patient populations and clinical settings. The findings below highlight reported performance from selected research and should be interpreted within the design, population, and limitations of each study.
Observed in a 688-participant, single-center pivotal clinical study.
Observed in the same study using a 15% prevalence assumption.
Research supporting Medical AI’s broader ECG-AI platform and clinical development program.
AiTiA LVSD analyzes numerical data from a routine 12-lead ECG acquisition.
Clinical Interpretation
In a reported pivotal-study subgroup with paired in-vitro diagnostic results, AiTiA LVSD achieved an AUROC of 0.905, compared with 0.720 for NT-proBNP.
The platform is intended to complement—not replace—biomarkers, echocardiography, physician evaluation, or other standard-of-care diagnostics.
Connected Research Environment
Today’s research. Tomorrow’s clinical insight.
A standard 12-lead ECG anchors a research pathway that keeps routine clinical care separate from background AI analysis, performance validation, and regulatory review.
Clinical Foundation
Standard
12-Lead ECG
12-Lead ECG
A familiar test anchors the entire study workflow.
01
Routine
Clinical Care
Clinical Care
The provider continues its established ECG workflow and makes clinical decisions without AI results.
02
Secure Research
Transfer
Transfer
Eligible ECG data move through the configured and protected study environment.
03
Silent AI
Analysis
Analysis
AiTiA LVSD analyzes numerical data from qualifying ECGs in the background for research purposes.
04
Performance
Validation
Validation
Study data support assessment of algorithm performance and real-world workflow integration.
05
FDA Review
Process
Process
Study data support clinical validation, workflow evaluation, and ongoing regulatory review.
06
Potential Clinical
Availability
Availability
Following regulatory authorization, AiTiA LVSD is intended for commercial clinical use under applicable agreements.
Silent Mode
The study operates in the background—not at the point of care.
Participating sites continue their established 12-lead ECG workflow. Qualifying ECG data is securely transferred to the configured research environment, where AiTiA LVSD performs background analysis while the clinical workflow remains unchanged. Results remain hidden from clinicians throughout Silent Mode. Physicians continue to evaluate and treat patients using the same clinical information and standards of care they rely on today.
01
Perform the ECG
The site completes a standard 12-lead ECG as part of its normal patient-care workflow.
02
Transfer the Data
Qualifying ECG data is securely transferred to the configured research environment.
03
Analyze Silently
AiTiA LVSD analyzes qualifying ECG data without displaying results to the provider.
04
Build the Evidence
The resulting dataset supports performance validation, regulatory review, and evaluation of potential future clinical use.
Why Silent Mode Matters
Real-world validation without changing patient care.
Silent Mode enables Medical AI and participating research sites to evaluate technical performance, secure data transfer, operational fit, and workflow integration while FDA review is ongoing. AI output remains hidden from treating clinicians and plays no role in patient diagnosis, treatment, or clinical decision-making during the Silent Mode study.
Potential Future Clinical Use
FDA review is ongoing. Following regulatory authorization and commercial availability under applicable agreements, AiTiA LVSD is intended to provide physicians with an additional ECG-based risk signal that may support decisions about follow-up evaluation. Any retrospective access to study analyses or prospective clinical use remains subject to regulatory requirements and the final commercial arrangement.
Participation Overview
What organizations can expect.
Before activation, each qualified organization reviews the equipment, operational responsibilities, compensation terms, data provisions, installation process, and study requirements documented in the applicable agreement and Silent-Mode Research Protocol.
$25 per qualifying ECG
Eligible sites receive research-support compensation for qualifying administrative, technical, and ECG data-collection activities, subject to the executed agreement.
- Payment eligibility begins after the site enrolls and transmits at least 10 qualifying unique-patient ECG studies; no per-ECG payment is owed if fewer than 10 are enrolled during the study.
- After the initial threshold is met, compensation is calculated monthly for incremental qualifying ECGs submitted during each calendar month.
- Payments continue until aggregated study participation reaches the maximum cap of 1,000 qualifying ECG studies.
- Compensation reflects bona fide research-support services and is not intended to induce or reward referrals, purchasing decisions, clinical utilization, reimbursable-service volume, or patient outcomes.
Designed for continuity beyond the study
During the Silent Mode Study, AI results remain hidden while ECG data support ongoing validation. Following FDA authorization, participating organizations may elect to transition to clinical use.
- Access AI results generated during the Silent Mode Study after FDA authorization as part of continued clinical deployment.
- Begin using FDA-authorized AI results within the clinical workflow.
- Expand the platform with future FDA-authorized AI algorithms as they become available.
Coordinated site activation
GE HealthCare and Medical AI coordinate the equipment, software, training, and operational-readiness activities required before study participation begins.
- Agreement execution occurs before Medical AI initiates equipment shipment.
- GE HealthCare performs delivery, installation, setup, and on-site staff training.
- Medical AI provides software support and implementation coordination with GE HealthCare.
- Research activity begins after installation, training, and confirmation that the site is operationally ready.
Protected research data
ECG and related research data are handled in accordance with the privacy, security, regulatory, and data governance requirements established in the executed study agreement.
- The participating organization retains ownership of identifiable patient data.
- De-identified ECG waveform data and related metadata may be used for research, analytical validation, regulatory submissions, algorithm development, and quality improvement as permitted by the agreement.
- De-identified data may be transferred to Medical AI's secure cloud environment and affiliated vendors only when it contains no protected health information and does not permit re-identification.
- Medical AI retains ownership of anonymized data and algorithmic outputs as provided in the executed agreement.
Participating Sites
Built for organizations where ECGs are already part of care.
The Silent Mode Study is designed for qualified healthcare organizations that routinely perform standard 12-lead ECGs. Final eligibility depends on patient volume, workflow readiness, data connectivity, study requirements, and execution of the participation agreement.
01
Hospitals
Hospitals
Multi-Specialty Groups
Organizations with established ECG workflows that support participation in real-world clinical research.
02
Cardiology
Cardiology practices that routinely perform ECGs and evaluate patients for left ventricular systolic dysfunction, supporting future integration of FDA-authorized AI analysis into clinical care.
03
Primary Care
Primary Care
Internal Medicine
Clinicians who encounter cardiovascular risk factors before referral to specialty care.
04
Emergency
Emergency
Urgent Care
Departments where standard 12-lead ECGs are routinely performed during rapid patient evaluation.
05
Concierge
Concierge
Executive Health
Practices providing comprehensive preventive medicine, executive health evaluations, and cardiovascular risk assessment.
Site Enablement
Everything required for participation is coordinated for the site.
Medical AI and its implementation partner, GE HealthCare, coordinate the equipment, software, installation, configuration, staff training, and technical support required for study participation. These resources are provided to the participating organization at no cost during the study. Medical AI retains ownership of all study equipment, which is provided solely for participation in the research program.
01
GE MAC 5 ECG system mounted on a mobile cart with standard accessories.
02
GE MUSE NX ECG management system, installed and configured for the study workflow.
03
Secure Microsoft Azure cloud connectivity for the transmission and storage of qualifying ECG data within the configured research environment.
04
AiTiA LVSD operating in Silent Mode, analyzing qualifying ECGs within the research environment while keeping AI results hidden from participating clinicians.
05
Delivery, installation, configuration, and training coordinated by GE HealthCare in collaboration with Medical AI.
06
Technical support and maintenance coordination provided throughout the study period to support continued operation of the research environment.
Beyond a Single Algorithm
Built for the future of ECG intelligence.
The current Silent Mode Study focuses on AiTiA LVSD, but the underlying platform is intended to support a broader portfolio of AI-enabled ECG analyses over time.
As additional algorithms complete clinical validation and receive applicable regulatory authorization, providers may be able to evaluate a broader range of cardiovascular conditions through the same established ECG workflow.
For participating organizations, the Silent Mode Study represents more than a single research initiative. It provides an opportunity to participate in the early development of an ECG-AI platform designed to evolve with future clinical applications.
Technology & Provider Partnership
Built by Medical AI. Brought to providers through CG Moneta.
Medical AI develops the AiTiA ECG-AI platform through the expertise of physicians, clinical researchers, AI scientists, and software engineers. Its clinical program includes peer-reviewed research, international hospital adoption, and continued advancement of ECG-AI technology across regulated healthcare markets.
CG Moneta is introducing qualified U.S. healthcare organizations to the AiTiA LVSD Silent Mode Study and supporting provider engagement, study evaluation, and future clinical commercialization subject to regulatory authorization.
145+
Hospitals Worldwide
120,000+
Monthly Paid Users
65+
Scientific Papers
444+
Patent Portfolio
Company metrics are based on information provided by Medical AI and may change over time. Study eligibility, commercialization timing, and U.S. product availability remain subject to regulatory authorization, implementation readiness, and applicable agreements.
Study Participation
Help shape what comes next.
CG Moneta is working with qualified healthcare organizations to evaluate participation in the AiTiA LVSD Silent Mode Study. Participating sites can contribute to the real-world validation of an ECG-AI platform while continuing their established standards of care.
Request study information to review site eligibility, workflow requirements, implementation support, research-support compensation, data provisions, agreement terms, and anticipated activation timing.
AiTiA LVSD is currently being evaluated in the United States through the Silent Mode Study. FDA review is ongoing, and the platform is not currently authorized for commercial clinical use in the United States. AI-generated results are not available to participating providers for clinical decision-making during the Silent Mode Study. Any future access to study analyses or prospective clinical use would occur following regulatory authorization and in accordance with applicable requirements and agreements. AiTiA LVSD is not intended to replace physician judgment or establish a diagnosis.
