[{"innerBlocks":[],"name":"core\/freeform","postId":176,"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":"An echocardiogram-based algorithm developed by digital health vendor Eko, in collaboration with the Mayo Clinic, has been granted \u201cbreakthrough device\u201d designation by the Food and Drug Administration.The FDA\u2019s Breakthrough Devices Program\u2014a voluntary program\u2014was first authorized in late 2016 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 disease or condition that have significant advantages over existing treatment or diagnostic alternatives.The provider-vendor partnership has combined Mayo\u2019s machine-learning algorithm and cardiovascular database\u2014which contains millions of ECGs and healthcare screenings\u2014with Eko\u2019s DUO smart stethoscope and software platform.

The machine learning algorithm, which analyzes 15 seconds of ECG data collected from Eko\u2019s digital stethoscope during a standard physical exam, screens patients for low ejection fraction to determine if there are problems with the heart\u2019s pumping function. \u201cA 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,\u201d says Paul Friedman, MD, chair of the Department of Cardiovascular Medicine at the Mayo Clinic in Rochester, Minn.\u201cThis technology gives physicians a tool to detect heart disease earlier and before it develops into a more serious illness,\u201d adds Friedman, who\u2014along with the Mayo Clinic\u2014has a financial interest in the technology. \u201cIn effect, by imbedding the technology in a commonly used clinical tool\u2014the stethoscope\u2014all caregivers carry some of the diagnostic prowess of an expert cardiologist with them.\u201dIn 2017, Eko received FDA clearance to market DUO, which combines ECG and digital stethoscope technology into a handheld device. According to the company, the problem with echocardiography is that it is an expensive and time-consuming medical imaging test using ultrasound that is less accessible than a doctor with a stethoscope.\u201cThe 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,\u201d said Connor Landgraf, CEO and co-founder of Eko. \u201cWe 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.\u201dRevenue from commercialization of the product will be used to support the Mayo Clinic\u2019s not-for-profit mission in patient care, education and research, according to the healthcare organization. ","saveContent":"An echocardiogram-based algorithm developed by digital health vendor Eko, in collaboration with the Mayo Clinic, has been granted \u201cbreakthrough device\u201d designation by the Food and Drug Administration.The FDA\u2019s Breakthrough Devices Program\u2014a voluntary program\u2014was first authorized in late 2016 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 disease or condition that have significant advantages over existing treatment or diagnostic alternatives.The provider-vendor partnership has combined Mayo\u2019s machine-learning algorithm and cardiovascular database\u2014which contains millions of ECGs and healthcare screenings\u2014with Eko\u2019s DUO smart stethoscope and software platform.

The machine learning algorithm, which analyzes 15 seconds of ECG data collected from Eko\u2019s digital stethoscope during a standard physical exam, screens patients for low ejection fraction to determine if there are problems with the heart\u2019s pumping function. \u201cA 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,\u201d says Paul Friedman, MD, chair of the Department of Cardiovascular Medicine at the Mayo Clinic in Rochester, Minn.\u201cThis technology gives physicians a tool to detect heart disease earlier and before it develops into a more serious illness,\u201d adds Friedman, who\u2014along with the Mayo Clinic\u2014has a financial interest in the technology. \u201cIn effect, by imbedding the technology in a commonly used clinical tool\u2014the stethoscope\u2014all caregivers carry some of the diagnostic prowess of an expert cardiologist with them.\u201dIn 2017, Eko received FDA clearance to market DUO, which combines ECG and digital stethoscope technology into a handheld device. According to the company, the problem with echocardiography is that it is an expensive and time-consuming medical imaging test using ultrasound that is less accessible than a doctor with a stethoscope.\u201cThe 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,\u201d said Connor Landgraf, CEO and co-founder of Eko. \u201cWe 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.\u201dRevenue from commercialization of the product will be used to support the Mayo Clinic\u2019s not-for-profit mission in patient care, education and research, according to the healthcare organization. ","order":0,"get_parent":{},"attributes":[],"attributesType":{"content":{"type":"string","source":"raw"},"lock":{"type":"object"}},"dynamicContent":""}]

AI heart failure algorithm receives FDA ‘breakthrough device’ designation

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