[{"innerBlocks":[],"name":"core\/freeform","postId":52,"blockType":{"name":"core\/freeform","keywords":[],"attributes":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"providesContext":[],"usesContext":[],"selectors":[],"supports":{"className":false,"customClassName":false,"reusable":false},"styles":[],"variations":[],"apiVersion":3,"title":"Classic","description":"Use the classic WordPress editor.","category":"text"},"originalContent":"The Food and Drug Administration has given clearance to algorithms for the detection of atrial fibrillation and heart murmurs, when used in combination with a digital stethoscope.Developed by digital health vendor Eko, the company contends that their artificial intelligence-powered stethoscope is the first to screen for these serious cardiovascular conditions and will enable providers to make more accurate patient diagnoses during routine physical exams.

According to Connor Landgraf, Eko\u2019s co-founder and CEO, the company\u2019s AI software puts the \u201cears of a cardiologist\u201d in a clinician\u2019s stethoscope by accurately analyzing electrocardiogram and heart phonocardiogram (heart sound) data.\u201cWe interpret those (cardiac data) to identify whether a patient has a murmur in a heart sound or whether they have an arrhythmia in the ECG,\u201d says Landgraf. \u201cWhat our technology does is allow the clinician to do a very quick screening test in the office that is highly accurate.\u201dWhen analyzing the one-lead ECG tracing from the Eko DUO stethoscope, the AI is able to detect AFib with 99 percent sensitivity and 97 percent specificity, notes Landgraf. At the same time, he points out that Eko\u2019s AI identifies heart murmurs with 87 percent sensitivity and 87 percent specificity.Northwestern Medicine, which helped Eko to build the algorithms and to test them, served as a clinical study site for the technology.\u201cTwo centuries after its invention, the stethoscope is still the front-line tool to detect cardiovascular disease,\u201d says Patrick McCarthy, MD, executive director of the Bluhm Cardiovascular Institute at Northwestern Medicine and a member of the Eko scientific advisory board. \u201cEko\u2019s development of artificial intelligence algorithms to help clinicians better interpret sounds, identify arrhythmias and detect heart murmurs during a physical exam is going to make a huge difference in our ability to care for patients.\u201dIn December, Eko announced that an ECG-based algorithm\u2014developed in collaboration with the Mayo Clinic\u2014was granted \u201cbreakthrough device\u201d designation by the FDA and, if cleared by the agency, could offer an easy and accessible screening test for heart failure.The FDA\u2019s voluntary Breakthrough Devices Program\u2014first authorized in late 2016\u2014seeks to preserve the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization, while providing timely access to new solutions for treating or diagnosing a disease or condition that have significant advantages over existing treatment or diagnostic alternatives.Going forward, Landgraf says Eko\u2019s AFib and heart murmur algorithms are the first in a suite of cardiac screening algorithms that the company plans to combine with its digital stethoscope. \u201cYou can\u2019t beat the traditional stethoscope in terms of its simplicity and ability to quickly determine how a patient\u2019s heart is functioning\u2014and, what we want to do with this digital augmentation is to give clinicians so much more data and insight,\u201d he adds. \u201cWe really want to be able to give every frontline clinician the confidence of a cardiologist.\u201d","saveContent":"The Food and Drug Administration has given clearance to algorithms for the detection of atrial fibrillation and heart murmurs, when used in combination with a digital stethoscope.Developed by digital health vendor Eko, the company contends that their artificial intelligence-powered stethoscope is the first to screen for these serious cardiovascular conditions and will enable providers to make more accurate patient diagnoses during routine physical exams.

According to Connor Landgraf, Eko\u2019s co-founder and CEO, the company\u2019s AI software puts the \u201cears of a cardiologist\u201d in a clinician\u2019s stethoscope by accurately analyzing electrocardiogram and heart phonocardiogram (heart sound) data.\u201cWe interpret those (cardiac data) to identify whether a patient has a murmur in a heart sound or whether they have an arrhythmia in the ECG,\u201d says Landgraf. \u201cWhat our technology does is allow the clinician to do a very quick screening test in the office that is highly accurate.\u201dWhen analyzing the one-lead ECG tracing from the Eko DUO stethoscope, the AI is able to detect AFib with 99 percent sensitivity and 97 percent specificity, notes Landgraf. At the same time, he points out that Eko\u2019s AI identifies heart murmurs with 87 percent sensitivity and 87 percent specificity.Northwestern Medicine, which helped Eko to build the algorithms and to test them, served as a clinical study site for the technology.\u201cTwo centuries after its invention, the stethoscope is still the front-line tool to detect cardiovascular disease,\u201d says Patrick McCarthy, MD, executive director of the Bluhm Cardiovascular Institute at Northwestern Medicine and a member of the Eko scientific advisory board. \u201cEko\u2019s development of artificial intelligence algorithms to help clinicians better interpret sounds, identify arrhythmias and detect heart murmurs during a physical exam is going to make a huge difference in our ability to care for patients.\u201dIn December, Eko announced that an ECG-based algorithm\u2014developed in collaboration with the Mayo Clinic\u2014was granted \u201cbreakthrough device\u201d designation by the FDA and, if cleared by the agency, could offer an easy and accessible screening test for heart failure.The FDA\u2019s voluntary Breakthrough Devices Program\u2014first authorized in late 2016\u2014seeks to preserve the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization, while providing timely access to new solutions for treating or diagnosing a disease or condition that have significant advantages over existing treatment or diagnostic alternatives.Going forward, Landgraf says Eko\u2019s AFib and heart murmur algorithms are the first in a suite of cardiac screening algorithms that the company plans to combine with its digital stethoscope. \u201cYou can\u2019t beat the traditional stethoscope in terms of its simplicity and ability to quickly determine how a patient\u2019s heart is functioning\u2014and, what we want to do with this digital augmentation is to give clinicians so much more data and insight,\u201d he adds. \u201cWe really want to be able to give every frontline clinician the confidence of a cardiologist.\u201d","order":0,"get_parent":{},"attributes":[],"attributesType":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"dynamicContent":""}]

FDA clears AI algorithms for detecting AFib, heart murmurs

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