FDA Clears New Electrocardiogram Suite of Algorithms and Analytics

While noise contamination has been an issue with electrocardiograms (ECGs), a newly FDA-cleared suite of ECG algorithms may bolster signal clarity and detection of cardiac conditions.

Featuring unique signal processing technology, the HeartKey Rhythm suite facilitates noise reduction and improved data quality with ECGs, according to B-Secur, the developer of HeartKey Rhythm.¹ The company maintains that the HeartKey Rhythm suite provides an antidote for challenges with ECG interpretation, citing a 2020 survey in which 53 percent of clinicians noted difficulty with interpreting remote ECGs.²

"There is an ever-increasing reliance on ECG data collected outside of a controlled clinical environment," said Adrian Condon, the chief technology officer and co-founder of B-Secur. "Our breakthrough FDA cleared product, HeartKey Rhythm, significantly improves the ECG signal processing and rhythm recognition of ambulatory devices and platforms."

The company added that on-chip solutions with the HeartKey Rhythm suite can be utilized for patient wearable devices, further facilitating timely care for common cardiac conditions.

References

1. B-Secur. B-Secur elevates proactive, efficient cardiac care with FSA-cleared HeartKey Rhythm solution. PR Newswire. Available at: https://www.prnewswire.com/news-releases/b-secur-elevates-proactive-efficient-cardiac-care-with-fda-cleared-heartkey-rhythm-solution-302236210.html?tc=eml_cleartime . Published September 3, 2024. Accessed September 5, 2024.

2. Ding EY, Svennberg E, Wurster C, et al. Survey of current perspectives on consumer-available digital health devices for detecting atrial fibrillation. Cardiovasc Digit Health J. 2020;1(1):21-29.