2024

Design Awards Gold Winner - AliveCor

Kardia 12L ECG System

Entrant Company

AliveCor

Category

Medical Devices & Technology - Medical Devices

Client's Name

Country / Region:

United States

A pioneer in accessible cardiac care, AliveCor has been committed to delivering affordable and innovative cardiac solutions since its inception. In June 2024, the company introduced the Kardia 12L ECG System, a first-of-its-kind device that significantly enhances the accessibility and efficiency of 12-lead ECG technology. The Kardia 12L is a portable, FDA-cleared, AI-powered 12-lead ECG device designed exclusively for use by healthcare professionals.

Powered by AliveCor’s revolutionary KAI 12L AI algorithm, this system simplifies ECG recordings with AI that is substantially equivalent to state-of-the-art ECG analysis solutions. It aids physicians in detecting 35 determinations (14 arrhythmias and 21 morphologies), including serious conditions like acute myocardial infarction (MI), commonly known as heart attack, and the most common types of cardiac ischemia. The device uses Bluetooth technology to wirelessly transmit ECG data to clinicians’ smartphones or tablets via AliveCor’s clinician-facing KardiaStation app, providing a detailed view of patients' heart activity within minutes.

The Kardia 12L stands out as the world’s first AI-powered, handheld 12-lead ECG system, featuring a unique single-cable design and just five electrodes—half the number used in traditional 12-lead ECG machines. This streamlined leadset enhances patient comfort and reduces invasiveness, eliminating the need for fully disrobing as with conventional ECGs. The system is compatible with both tab (resting) and snap (active) electrodes, which minimizes the use of adhesive – making it suitable for sensitive skin. Its intuitive interface requires minimal training, and at just 0.3 pounds, the device is highly portable, easily fitting into a physician’s labcoat pocket.

Conventional 12-lead ECG machines are the standard of care for detecting and diagnosing many heart conditions, but their availability can be limited due to their size and complexity. Kardia 12L addresses these limitations, offering a compact, easy-to-use solution that empowers healthcare providers with rapid data collection in various settings, including primary and urgent care offices, employer clinics and other under-resourced or rural venues. Recently, the Kardia 12L was granted new Category III Current Procedural Terminology (CPT) codes–widely used by government payers and commercial insurance companies for reimbursement–paving the way to bring this groundbreaking ECG technology to patients everywhere.

Credits

Chief Executive Officer, AliveCor
Priya Abani
Founder and Chief Medical Officer, AliveCor
David E. Albert, MD
Chief Business Officer, AliveCor
Sanjay Voleti
Chief Financial Officer, AliveCor
Rojeh Avanesian
Chief Technology Officer, AliveCor
Siva Somayajula
Chief Product Officer, AliveCor
Alfred Woo
Chief Revenue Officer, Enterprise, AliveCor
Michael Rolla
Chief Marketing Officer - Consumer, AliveCor
Cora Locke
General Counsel, AliveCor
Bill Jacobs
Chief Human Resources Officer, AliveCor
Jon-Paul Ales-Barnicoat
Senior Vice President, Services, AliveCor
Ben Green, MD
Senior Vice President, Healthcare Enterprise, North America, AliveCor
Patricia Baran
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