FDA Clears First of its Kind Algorithm Suite for Personal ECG
MOUNTAIN VIEW, Calif., Nov. 23, 2020 /PRNewswire/ -- AliveCor, the leader in AI-based personal ECG technology and provider of enterprise cardiology solutions, today announced that the US FDA had given clearance to the company's next generation of interpretive ECG algorithms.
"Kardia AI V2 is the most sophisticated AI ever brought to personal ECG," said AliveCor CEO Priya Abani. "This suite of algorithms and visualizations will provide the platform for delivery of new consumer and professional service offerings beyond AFib, by allowing a much wider range of cardiac conditions to be determined on a personal ECG device."
AliveCor's KardiaMobile and KardiaMobile 6L devices, along with the Kardia app, allow users to take a 30-second ECG and receive instant determinations of multiple cardiac conditions. This new FDA 510(K) clearance provides detail and fidelity unlike any previously seen in personal ECG devices including:
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:
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. For more information, visit alivecor.com.
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