KardiaMobile - AI-Powered Portable ECG Device | FDA-Cleared

AliveCor KardiaMobile  AI-Powered Portable ECG Device represents a breakthrough in consumer cardiac monitoring, delivering FDA-cleared, medical-grade electrocardiogram (ECG) analysis through smartphone-connected devices combined with artificial intelligence. This portable cardiac screening technology empowers patients and clinicians to detect atrial fibrillation (AFib), bradycardia, tachycardia, and other arrhythmias instantly—transforming cardiac monitoring from episodic clinic visits to continuous, at-home surveillance that catches dangerous rhythm disturbances when they occur.

The Arrhythmia Detection Challenge

Cardiac arrhythmias affect over 33 million people worldwide, with atrial fibrillation alone impacting 6+ million Americans. These rhythm disorders significantly increase stroke risk, heart failure, and sudden cardiac death. The critical problem: arrhythmias are often paroxysmal (intermittent), occurring unpredictably and frequently resolving before patients reach medical facilities.

Traditional detection methods have significant limitations:

• 12-lead ECG in clinic: Only captures heart rhythm during brief office visit, missing intermittent arrhythmias
• Holter monitors: 24-48 hour recording windows still miss infrequent episodes
• Event monitors: Require patients to activate during symptoms, missing asymptomatic episodes
• Implantable loop recorders: Invasive, expensive, limited to high-risk patients
• Access barriers: Many patients lack convenient cardiology access for monitoring

Each undetected AFib episode represents stroke risk. Studies show AFib patients have 5x higher stroke incidence, yet 25-30% of AFib cases remain undiagnosed until a catastrophic event occurs.

How KardiaMobile Works

Medical-Grade ECG Capture

AliveCor’s devices are compact sensors that connect wirelessly to smartphones or tablets. Users simply place fingers on electrode pads, and within 30 seconds, the device captures a single-lead or six-lead ECG (depending on model) comparable in quality to clinical equipment.

Product Line:

• KardiaMobile: Single-lead ECG, credit-card sized, captures Lead I
• KardiaMobile 6L: Six-lead ECG providing comprehensive cardiac view including anterior, lateral, and inferior leads
• KardiaStation: In-clinic solution for healthcare provider use

Instant AI Analysis

The moment an ECG is captured, AliveCor’s FDA-cleared AI algorithms analyze the recording:

• Normal Sinus Rhythm: Confirms healthy heart rhythm
• Atrial Fibrillation: Detects irregular rhythm indicating AFib
• Bradycardia: Identifies abnormally slow heart rate (<50 bpm)
• Tachycardia: Flags abnormally fast heart rate (>100 bpm)
• Unclassified: Indicates recording requires physician review

Analysis occurs in seconds, providing immediate feedback patients can act upon—calling emergency services for concerning findings or documenting episodes for physician review.

Advanced Detection (KardiaCare Subscription)

Premium AI features detect additional conditions:

• Premature Ventricular Contractions (PVCs)
• Sinus rhythm with supraventricular ectopy (SVE)
• Sinus rhythm with wide QRS
• Long QT interval (sudden cardiac death risk factor)

Comprehensive Tracking & Sharing

The Kardia app stores unlimited ECG recordings with timestamps, symptoms, and medication tracking. Users can:

• Generate PDF reports for physician appointments
• Share recordings directly with cardiologists via secure messaging
• Track correlation between activities, medications, and arrhythmia episodes
• Monitor treatment effectiveness over time

Clinical Validation & Performance

FDA Clearance: Multiple FDA 510(k) clearances for AFib detection, bradycardia, tachycardia, and normal sinus rhythm determination validate clinical accuracy.

Peer-Reviewed Evidence:

• 97-98% sensitivity for AFib detection in validation studies
• Agreement with 12-lead ECG exceeding 95% for rhythm classification
• Over 150 peer-reviewed publications demonstrating clinical utility
• Apple Heart Study: Validated KardiaMobile for confirming Apple Watch AFib notifications

Real-World Use: Over 100 million ECGs recorded worldwide, making Kardia the most extensively validated consumer cardiac device.

Clinical Benefits

Early AFib Detection: Studies show Kardia increases AFib diagnosis rates by 3-5x compared to standard care, enabling anticoagulation therapy that prevents strokes.

Symptom-Rhythm Correlation: Patients experiencing palpitations, dizziness, or chest discomfort can immediately capture ECG during symptoms, solving the “missed episode” problem that plagues traditional monitoring.

Treatment Monitoring: AFib patients can verify medication effectiveness or document breakthrough arrhythmias between cardiology appointments.

Post-Ablation Surveillance: Cardiac ablation patients can monitor for AFib recurrence without waiting months for follow-up appointments.

Remote Patient Management: Enables cardiologists to monitor high-risk patients continuously without expensive implantable devices.

Peace of Mind: Patients with cardiac anxiety can quickly verify normal rhythm, reducing emergency department visits for benign palpitations.

Use Cases

AFib Screening: Primary care physicians can screen high-risk patients (age 65+, hypertension, diabetes) for undiagnosed AFib.

Cryptogenic Stroke Workup: Patients with unexplained stroke undergo extended monitoring for paroxysmal AFib.

Palpitation Evaluation: Replaces or supplements event monitors for symptom-rhythm correlation.

Post-Operative Monitoring: Tracks cardiac surgery patients for arrhythmia complications.

Athlete Screening: Monitors competitive athletes for exercise-induced arrhythmias.

Telehealth Integration: Facilitates virtual cardiology consultations with objective cardiac data.

Pricing & Accessibility

Device Costs:

• KardiaMobile: $79-99
• KardiaMobile 6L: $149-169

KardiaCare Subscription (optional): $99/year or $10/month for advanced detection algorithms, unlimited cloud storage, and clinician report generation.

Insurance Coverage: Many insurance plans and HSA/FSA accounts cover Kardia devices. Some cardiologists prescribe devices for reimbursement.

Who Should Use KardiaMobile

• AFib patients monitoring rhythm control
• Individuals with palpitations seeking symptom correlation
• Stroke survivors undergoing extended AFib screening
• High-risk patients (age 65+, hypertension, heart disease)
• Cardiac medication users tracking treatment response
• Healthcare providers conducting in-office or remote monitoring

Limitations & Considerations

KardiaMobile is a screening tool, not a replacement for comprehensive cardiac evaluation. It detects specific arrhythmias but cannot diagnose heart attacks, evaluate cardiac structure, or detect all rhythm abnormalities. Patients with concerning findings should always consult healthcare providers.

Conclusion

AliveCor KardiaMobile democratizes cardiac monitoring through affordable, medical-grade technology that places ECG capability in patients’ pockets. With FDA clearance, extensive clinical validation, and over 100 million recorded ECGs, Kardia represents the gold standard in consumer cardiac monitoring—enabling early detection, continuous surveillance, and potentially life-saving interventions for millions at risk of stroke and sudden cardiac events.