AccurKardia's automated ECG analysis software snags FDA nod

With cases of arrhythmia and heart disease on the rise—thanks in large part to an aging global population—more tools and technologies are needed to speed up the process of diagnosing and beginning treatment for these and other heart conditions.

Coming right up: The FDA has cleared a new software platform that fully automates the process of interpreting electrocardiograms, helping triage potential cases of irregular heart rhythms. The software comes from New York City-based AccurKardia, which announced the regulatory news this week.

The AccurECG system was cleared to analyze results for patients aged 22 and older.

AccurKardia’s software relies on artificial intelligence algorithms and other technologies to scan readouts collected by a variety of compatible ECG devices. It parses through the peaks and valleys of each readout, performing beat-by-beat analyses, measuring each patient’s heart rate and looking for specific indicators of cardiac conditions.

The analysis takes only a few minutes, per AccurKardia. Once finished, the system churns out a report that highlights signs of a baker’s dozen abnormal heart rhythms—including atrial fibrillation, tachycardia, bradycardia and more.

In a retrospective study of the technology that AccurKardia included in its application to the FDA, researchers found that AccurECG was able to detect those 13 forms of arrhythmia with about 96% sensitivity and 99% specificity.

AccurKardia is hoping that its software—which is housed on the cloud and can slot into a hospital or clinic’s existing cardiac workflows—will bring “specialist-level ECG interpretation” within reach for doctors and patients across the U.S. who may not otherwise have access to that level of analysis, Chief Medical Officer Nav Razvi, M.D., said in the announcement.

“By providing a device-agnostic, medical-grade solution with explainable output and no ‘black box’ approach, we aim to empower healthcare providers with accurate, fast, efficient and transparent ECG interpretation,” CEO Juan Jiménez added.

AccurKardia is far from alone in developing new tools to automatically spot signs of arrhythmia and other heart conditions. Medtech makers like Eko, iRhythm and more are infusing AI into clinical tools, patient monitoring devices and software platforms to catch the conditions as early and accurately as possible.

And beyond the traditional realm of medtech, consumer tech giants like Apple, Fitbit and Samsung have all added afib detection features to their respective smartwatches, making arrhythmia diagnoses even more broadly accessible.