One study evaluated the accuracy of the recordings and interpretations of the Kardia 12L device that records 12-lead ECG. It compared the accuracy of the AI-powered device to standard 12-lead ECG technology.
Kardia 12L uses a deep neural network model, expanding eight leads into a complete 12-lead ECG. In 150 participants, all measurements showed strong correlation, meaning Kardia’s evaluations are “highly similar” to standard 12-lead ECG, according to the study’s abstract. This enables the rapid acquisition of complete ECG information in clinical practice.
Another study compared six-lead Kardia ECG to the traditional Holter monitor. KardiaMobile 6L, an FDA-cleared, portable recording device enables patient-initiated recordings during symptoms, potentially enhancing diagnostic accuracy. This study looked to assess the system’s diagnostic yield compared to conventional Holter monitoring.
AliveCor’s study included 350 patients and performed 6,251 KardiaMobile 6L recordings during a 30-day period. The study found significant arrhythmias in 66 patients using any recording modality. The abstract says 27 (7.7%) came with Holters and 52 (14.9%) with KardiaMobile 6L. Notably, 39 (11.1%) of arrhythmias were only identified by KardiaMobile 6L.
Investigators concluded that KardiaMobile 6L-derived recordings significantly improve the detection of arrhythmias in symptomatic patients compared to Holter monitoring.
“These data demonstrate how the accuracy of Kardia 12L and KardiaMobile 6L can help facilitate expanded use of AI-guided ECG diagnosis across a wide range of clinical settings — empowering both consumers and healthcare providers with solutions that rival traditional devices, but with the added benefits of portability, ease of use and accessibility,” said Dr. David Albert, founder and chief medical officer of AliveCor.
