FDA grants Breakthrough designation for ECG-based algorithm

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The US Food and Drug Administration has granted Breakthrough Device designation to the digital health and artificial intelligence (AI) company Eko for an echocardiogram (ECG)-based algorithm to help identify induced Left Ventricular Ejection Fraction (LVEF).

FDA Breakthrough Device designation helps accelerate the algorithm’s regulatory review and is only awarded to novel innovations that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases.

The algorithm analyses 15 seconds of ECG data collected from the Eko DUO digital stethoscope during a physical exam and helps identify reduced LVEF, a measure commonly used to diagnose patients with heart failure.

Eko’s low ejection fraction algorithm employs a deep neural network developed in collaboration with Mayo Clinic. The algorithm was first announced in a publication in Nature Medicine in January 2019. In further clinical studies at Mayo Clinic, the DUO combined with the AI algorithm was able to detect ejection fraction < 35% with an area under the curve (AUC) of 0.90.

“The Breakthrough Device designation recognises the vast unmet clinical needs in identifying heart failure early in patients, whether it be due to cost, inaccessibility, or misdiagnosis,” said Connor Landgraf, CEO and co-founder of Eko. “We look forward to working with the FDA to bring this algorithm to patients and to give clinicians a new tool to screen for low ejection fraction.”

“A low ejection fraction means that the heart pump is weak, which can lead to shortness of breath, swelling, exercise intolerance, or sudden death, so it is important to identify, as many treatments exist,” said Paul Friedman (chair of the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, USA). “This technology gives physicians a tool to detect heart disease earlier, and before it develops into a more serious illness. In effect, by imbedding the technology in a commonly used clinical tool – the stethoscope – all caregivers carry some of the diagnostic prowess of an expert cardiologist with them.”


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