Novel algorithm for HF screening receives FDA breakthrough designation
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Eko announced that a novel ECG-based algorithm to screen for HF has been granted breakthrough device status from the FDA.
“Roughly 7 million Americans have a weak heart pump and don’t know it,” Paul A. Friedman, MD, chair of the department of cardiovascular medicine at Mayo Clinic in Rochester, Minnesota, told Healio. “They either have no symptoms or they may attribute their symptoms to other conditions. It’s important to be aware of the condition because once ventricular dysfunction is diagnosed — once you know that you have a weak heart pump — there are a number of established, proven therapies including medications and implantable devices that lower the risk of developing symptoms and the risk of death. By identifying people with these conditions, doctors can then offer them treatment sooner.”
The algorithm, which was developed in collaboration with Mayo Clinic, uses a deep neural network to analyze 15 seconds of ECG data obtained from a digital stethoscope (Eko DUO) during a physical examination. Through this, left ventricular ejection fraction can be identified, according to the release.
“The reason a stethoscope is a particularly useful form factor is that it is something that doctors, nurses and other health care providers have with them all the time, so it is part of their standard workflow,” Friedman said in an interview. “You’re not really changing how health care is currently delivered or how patients are seen. By integrating this seamlessly into the current workflow, it expands the opportunity of the tool being used because if you build a new tool that looks really promising, but is cumbersome, takes a lot of training or includes other impediments to adoption, it may never me used and people are not helped.”
Receipt of this designation from the FDA will help accelerate regulatory review of the algorithm, as it may potentially address unmet medical needs, according to the release.
“The breakthrough device designation recognizes the vast unmet clinical needs in identifying heart failure early in patients, whether it be due to cost, inaccessibility or misdiagnosis,” Connor Landgraf, CEO and co-founder of Eko, said in the release. “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.”
For more information:
Paul A. Friedman, MD, can be reached at friedman.paul@mayo.edu; Twitter: @drpaulfriedman.
Disclosures: Landgraf is an employee of Eko. Friedman reports he and his institution have a financial interest in this technology.