Bardy Diagnostics™ Announces Validation of AI-Enabled Automatic Screening Technology for Atrial Fibrillation

SEATTLE, May 9, 2018 — Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, including the Carnation Ambulatory Monitor ("CAM™"), the world's only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device, presented a poster today titled "Artificial Intelligence for the Automatic Detection of Atrial Fibrillation" at the Heart Rhythm Society 39th Annual Scientific Sessions that described a validated artificial intelligence-enabled (AI) screening technology to detect atrial fibrillation (AF) events.

The novel AF detection technology was developed using a machine learning technique that employs a convolutional, feed-forward neural network trained using P-wave centric CAM recordings consisting of 12 million ECG samples of persistent AF, paroxysmal AF, and no findings of AF. Additionally, specific "no findings of AF" training counter-examples incorporated beat-to-beat varying rhythms that are commonly mistaken for AF by many of the commercially-available, R-wave focused automated AF detectors, including dense atrial or ventricular ectopy, atrial flutter, and atrial tachycardia with variable conduction.

Commenting on this advancement, Bardy Diagnostics Founder and Chief Executive Officer, Gust H Bardy, MD, said, "Automated arrhythmia detection is a key component of our ongoing research and development efforts at BardyDx to advance and redefine the standard of care in cardiac monitoring." Dr. Bardy continued, "The CAM patch's distinctive P-wave centric design and low-amplitude signal detection presents the unique opportunity to leverage its high clarity ECG signal in developing a reliable detector that surpasses less accurate methods of algorithmic approaches using RR interval variability or AI methods weighted on R-wave analysis."

For an AF event spanning 10 minutes or longer, the detection technology's expert-validated sensitivity was 95% (p<0.01) and the specificity was 91% (p<0.02). Dr. Bardy said, "Diagnostic accuracy is of utmost importance in these types of automated approaches. False positive AF diagnoses can be particularly concerning given the profound harmful consequences of administering unnecessary anticoagulants, antiarrhythmic drugs, or procedural interventions."

The successful validation of this technology marks an important milestone in BardyDx's R&D pipeline of future AI-enabled diagnostic products with the potential for widespread public screening of atrial fibrillation and other arrhythmias. Dr. Bardy said, "This automatic AF detector is the first step into the development of AI-driven heart rhythm diagnostics that can accurately screen a broad list of arrhythmias; the CAM patch's powerful ability to bring detailed quality and character to the atrial ECG makes this all possible." 

About Bardy Diagnostics:

Bardy Diagnostics, Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing diagnostically-accurate and patient-friendly cardiac and vital signs patch monitors to the industry. The company's CAM patch is a non-invasive, P-wave centric™ ambulatory cardiac monitor and arrhythmia detection device that is designed to improve patient compliance for men, women, and children through its lifestyle-enabling patch design. Designed to be worn comfortably and discreetly by both men and women, the female-friendly, hourglass-shaped CAM patch is placed on the center of the chest, directly over the heart for optimum ECG signal collection. The innovative and broadly-patented technology of the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the part of the ECG waveform that is essential for accurate arrhythmia diagnosis.