Kardia 12L – Portable AI-Powered 12-Lead ECG System for Healthcare Professionals

Description

Advanced Cardiology Powered by AI

The Kardia 12L features a state-of-the-art ECG algorithm that has achieved FDA clearance based on substantial equivalence to the industry-standard GE HealthCare 12SL algorithm.

• Validated Accuracy: Trained and validated using 1.75 million ECGs from leading U.S. medical centers.

• Massive Dataset: Built on 1 million ECGs for training and 750k ECGs for rigorous validation.

Precision Lead Technology

Using sophisticated machine learning, the Kardia 12L provides comprehensive cardiac determinations:

• 8 Leads Total: High-fidelity data capture.

• 4 Recorded Leads: Standard diagnostic-bandwidth leads.

• 4 Derived Leads: Synthesized using advanced machine learning for a complete clinical picture.

Engineered for Portability & Speed

Designed for the fast-paced environment of acute care, the Kardia 12L removes the barriers of traditional ECG machines.

• Ultra-Lightweight: Weighing only 135.6g (approx), it fits in your pocket or a small kit.

• Wire-Free Design: No cables to detangle or maintain, making the system more intuitive and significantly less error-prone.

• Battery Operated: Fully portable for use anywhere in the facility without searching for an outlet.

Intuitive Ease of Use

Acquire an accurate ECG in minutes. The simplified interface and streamlined hardware mean that even healthcare professionals with infrequent ECG experience can operate the device with confidence and precision.

Technical Specifications (Product Data Tab)

Feature	Specification
Intended Use	Patients 18+ in healthcare facilities/acute settings
Operator	Healthcare professionals or trained personnel
Weight	~135.6 grams
Power Source	Battery-operated
Lead Count	8 Leads (4 Recorded + 4 Derived)
Algorithm	AI-based (Substantial equivalence to GE 12SL)
Connectivity	Wireless / Portable

Important Clinical Note

Kardia 12L is intended for use by healthcare professionals or trained personnel in healthcare facilities and in acute settings. Not intended for home use or use by patients under 18 years of age.