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FDA clears first of its kind algorithm suite for personal ECG

Press releases may be edited for formatting or style | November 23, 2020 Artificial Intelligence Cardiology
AliveCor expects this new suite of advanced determinations will augment telehealth services and provide the technology foundation for a new range of professional and consumer services including the launch of:

Advanced ECG determination services within KardiaCare, the company's remote heart care service for consumers.
The Kardia Heart Health Report (HHR), a cardiologist-backed patient heart risk assessment report.
A professional ambulatory monitoring service, using the AliveCor six-lead ECG device at home, bringing greater comfort and convenience over legacy technologies.
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Chronic heart disease management, which combines human-backed and digital care plans to manage the heart health of high-risk employee populations.
This new FDA clearance positions AliveCor to deliver AI-based remote cardiological services for the vast majority of cases when cardiac patients are not in front of their doctor. AliveCor's goal is to help cardiologists efficiently provide the best possible 24/7 service to their patients.

Today, KardiaMobile and KardiaMobile 6L are the most clinically validated personal ECG devices in the world, and provide instant detection of Normal Sinus Rhythm, Atrial Fibrillation, Bradycardia, and Tachycardia. The new determinations and services will be available in 2021.


About AliveCor, Inc.
AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically validated personal ECG solution in the world. KardiaMobile provides instant detection of atrial fibrillation, bradycardia, tachycardia, and normal heart rhythm in an ECG. Kardia is the first AI-enabled platform to aid patients and clinicians in the early detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. AliveCor's enterprise platform allows third party providers to manage their patients' and customers' heart conditions simply and profitably using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor protects its customers with stringent data security and compliance practices, achieving HIPAA compliance and SOC2 Type 1 and Type 2 attestations. AliveCor is a privately-held company headquartered in Mountain View, Calif. "Consumer" or "Personal" ECGs are ECG devices available for direct sale to consumers.


SOURCE AliveCor

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