May 2019 | FDA grants clearance for eMurmur ID, heart murmur detection solution on a personal mobile device
May 7, 2019
eMurmur® today announced that its flagship “eMurmur ID” solution has received FDA clearance, enabling a new era in heart murmur detection. eMurmur ID is a mobile and cloud solution which operates in conjunction with a 3rd party electronic stethoscope. It uses advanced machine learning to identify and classify pathologic and innocent heart murmurs, the absence of a heart murmur, and S1, S2 heart sounds. The end-to-end solution is comprised of AI-based analytics, a mobile app, and a web portal (all HIPAA compliant). It supports the workflows of healthcare providers performing cardiac auscultation and has multiple applications including primary and specialty care, and corporate health.
Heart Murmur Detection: Past vs Future
Heart disease is the leading cause of death globally for both men and women, causing 31% of all deaths annually. Heart auscultation (meaning “to listen with a stethoscope”) is a 200+ year-old method to screen for heart disease by listening for abnormal heart sounds (murmurs), used worldwide for patients of all ages. However, heart auscultation is subjective in nature and studies have shown accuracy rates amongst primary care providers to be as low as 20-25%. With an accuracy rate of over 85%, eMurmur ID makes expert-level auscultation accessible to any healthcare provider performing auscultation.
“The eMurmur ID solution has the potential to disrupt medical care”, said Dr. Derek Exner, Professor and Canada Research Chair in Cardiovascular Clinical Trials at the University of Calgary. “The evidence for its utility is solid and includes five studies on over 1000 patients, including blinded, multi-centre trials. This system has been shown to be accurate, informative, and easy-to-use. It provides healthcare professionals with a potent screening tool and method to confirm their clinical diagnoses, enhancing patient care.”
“Receiving FDA clearance marks a significant milestone in our company’s history, and I’m very excited to finally be able to take the eMurmur ID solution to market,” said Andreas Schriefl, co-founder and CEO of eMurmur. “We believe that eMurmur ID has the potential to disrupt the status-quo of heart murmur screening and significantly reduce costs to healthcare systems worldwide.”
“From a technology perspective, receiving FDA clearance requires solid clinical proof of the algorithm performance characteristics, as well as a quality and risk management system that ensures patient safety and compliance with stringent regulatory standards,” said Andreas Reinisch, co-founder and CTO of eMurmur. “Through this process, our company has gained significant knowledge and expertise to facilitate and support future AI- based medical solutions,”
About eMurmur (www.emurmur.com)
Founded in 2014, eMurmur is a privately-held medical technology company specializing in Machine Learning for the analysis of data for medical applications. eMurmur is the leader in automated heart murmur detection technology and has completed multiple prospective clinical studies in this field, demonstrating expert-level accuracy rates. In addition, the company’s intellectual property includes a proprietary database of 1000s of heart recordings with corresponding gold-standard echocardiogram diagnoses and cardiologist assessments. eMurmur also provides heart-auscultation educational solutions to leading medical schools. The company is headquartered in Ottawa, Canada (CSD Labs International), has R&D operations in Graz, Austria (CSD Labs), and does business under the name eMurmur.
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April 2019 | eMurmur releases Primer, accredited by Partners in Healthcare Education, LLC, accredited by the American Association of Nurse Practitioners
This month, we launched eMurmur Primer, an accredited app designed for nurse practitioners and nurses to improve their cardiac auscultation skills while earning continuing education credits. Creating an interactive and practical app for nurses took several months of development as we worked closely with several nurse practitioners and nurses to identify what they wanted in an app. We took their feedback to heart and used the library of 1,000 cardiologists-vetted, patient heart sounds from our clinical trials to design an app that would prime their cardiac auscultation skills. We partnered with top medical institutions to gather our research and design a straightforward continuing education course for use by any busy nurse. In one recent survey, we found that 7/10 nurses were not confident in identifying benign or pathological heart murmurs. To improve confidence in hearing heart murmurs and understanding the heart, we designed Primer based on the 3 Keys to Mastering Cardiac Auscultation by Cardiologist John P. Finley in his book Teaching Heart Auscultation to Health Professionals.
Download our app for free to understand heart anatomy, identify normal heart sounds versus abnormal, the difference between benign and pathological murmurs, and differentiate between murmurs that warrant further evaluation and those that do not with eMurmur Primer.
eMurmur Primer is accredited by Partners in Healthcare Education, LLC, accredited by the American Association of Nurse Practitioners
March 2019 | eMurmur Heartpedia launches in the Google Play and Apple App Store
Today, eMurmur announced the release of eMurmur Heartpedia, an app designed to help patients, parents and medical professionals to better understand heart defects through anatomically-correct 3D models and corresponding heart and murmur sound recordings for each defect. eMurmur Heartpedia is a major upgrade of the original Heartpedia app from Cincinnati Children’s Hospital Medical CenterCentre which has been downloaded over 100,000 times since its release in 2014.
"Congenital heart defects can be difficult to visualize, understand, and explain. Supplying easy-to-understand information on heart defects and established surgical repair strategies can result in improved comprehensive care for the patient,” says Peace Madueme, MD MS FAAP FACC FASE at Nemours Children’s Hospital in Orlando. "eMurmur Heartpedia is unique in that it provides validated patient heart sounds, 3D cardiac models and videos in an easy- to- use app that is accessible and understandable by anyone."
“The rich visual and audio heart information in eMurmur Heartpedia make it much easier to understand heart defects, which we expect will be invaluable to families, healthcare professionals, medical and nursing schools.” says Andreas Schriefl, founder and CEO of eMurmur
eMurmur Heartpedia is a downloadable app that runs on a mobile device such as a smartphone or tablet, and is available from both the IOS and Android app stores. Check out eMurmur Heartpedia in the Google Play and Apple App store.
Dec 2018 | Johns Hopkins study demonstrates 88% accuracy of eMurmur, as published in Pediatric Cardiology
Results from a study called "Artificial Intelligence-Assisted Auscultation of Heart Murmurs: Validation by Virtual Clinical Trial" have been published in the peer-reviewed journal of Pediatric Cardiology. This is the first reported comprehensive and objective evaluation of an AI-based murmur detection algorithm, and included 3180 heart sound recordings from 603 outpatient visits. Algorithm estimation of heart rate was similar to gold standard. Sensitivity and specificity for detection of pathologic cases were 93% (CI 90–95%) and 81% (CI 75–85%), respectively, with accuracy 88% (CI 85–91%). In conclusion, the eMurmur algorithm tested has high sensitivity and specificity for detection of pathologic murmurs, similar to levels reported for specialist auscultation, making it a potentially useful screening tool for heart disease.
Read the publication
Aug 2018 | eMurmur ID filed for FDA 510(k) and CE regulatory clearance
eMurmur announced today that it has submitted its clinical screening software tool to the US Federal Drug Administration (FDA) as part of an application for FDA 510(k) clearance. This filing is in addition to eMurmur’s application and filing for European CE regulatory clearance which was submitted in June 2018.
Jun 2018 | eMurmur graduates from Creative Destruction Labs
eMurmur announced today that it has successfully graduated from the Creative Destruction Labs (CDL), a highly competitive and successful seed-stage program for massively scalable, science-based companies. eMurmur participated in the 9-month program as part of the CDL-West’s health stream.
May 2018 | Dr. Derek Exner joins eMurmur as a medical advisor
eMurmur announces that renowned cardiologist, Dr. Derek Exner, Professor has joined its advisory board. Dr. Exner is Canada Research Chair, Cardiovascular Clinical Trials; Associate Dean, Clinical Trials, Cumming School of Medicine; and Professor, Department of Cardiac Sciences and Community Health Sciences, University of Calgary.
Feb 2018 | eMurmur opens North American sales and marketing office in Ottawa, Canada
eMurmur announced today that it has incorporated in Canada and opened an office in Ottawa to address the North America market in order to begin to build out its sales, marketing and market development team. eMurmur will continue to operate and grow its R&D facilities in Graz, Austria.
Nov 2017 | Data from comparative clinical study presented at AHA Scientific Sessions 2017
Dr. Lillian Lai of Children’s Hospital Eastern Ottawa presented a study today titled “Performance Evaluation of Two Heart Murmur Detection Applications by Prospective Clinical Trial” at the AHA Scientific Session 2017 today.
The study included 93 patients and demonstrated a sensitivity and specificity for automated detection of pathologic murmurs of 84.4% and 85.9%, respectively, with the gold standard being echocardiography, with eMurmur significantly outperform the other device.
Read the abstract
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Nov 2017 | Results from Johns Hopkins study presented at AHA Scientific Sessions 2017
In the AHA Scientific Session “Best Abstracts in Health Tech ”, Dr. W. Reid Thompson, associate professor of pediatrics at Johns Hopkins University, today presented a study titled “Validation of a Heart Murmur Algorithm by Virtual Clinical Trial” which used the eMurmur algorithm to blindly analyze 3,180 heart sound recordings from the Johns Hopkins Cardiac Auscultatory Recording Database (CARD). Study results showed a sensitivity of 93% and a specificity of 81%, as well as an accuracy of 88%.
Read the Abstract
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July 2017 | eMurmur’s heart murmur detection algorithm scores 89% sensitivity in an elderly population clinical trial
eMurmur announces completion of a clinical trial evaluating the performance of its heart murmur detection algorithms on an elderly population with congenital heart disease. The algorithm’s sensitivity for autonomous detection of pathologic murmurs was 89%. No high severity cases were missed by the algorithm. Further, it yielded accurate heart rate estimation and S1/S2 detection, despite the presence of significant environmental noise.
Read the abstract
Nov 2016 | eMurmur’s heart murmur detection algorithm scores 94% accuracy in clinical pilot study
eMurmur announces impressive pilot study of its AI platform on 106 children at Children’s Hospital of Eastern Ontario, Canada, where it differentiated pathologic from innocent heart murmurs with high sensitivity (87%) and specificity (100%), a positive predictive value of 100%, a negative predictive value of 90%, and high accuracy (94%) when compared with echocardiography as the gold standard for diagnosing murmurs.
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Oct 2016 | Dr. Andrew Redington joins as a medical advisor
eMurmur announces Andrew Redington, MD, an internationally renowned cardiologist and Chief of Pediatric Cardiology at Cincinnati Children’s Hospital in Ohio, United States, joins the company as a medical advisor.
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May 2016 | Dr. Lillian Lai joins as a medical advisor
eMurmur announces that Lillian Lai, MD, Cardiologist at Children's Hospital of Eastern Ontario, Canada joins the company as a medical advisor. Dr. Lai previously served as a Principal Investigator on several clinical studies for the development and validation of the eMurmur technology.
Feb 2016 | eMurmur recipient of major Austrian government funding
eMurmur approved to receive up to EUR 600,000 in Seed financing from the Austrian government, aimed to help transform well formulated business ideas around innovative technologies into a start-up ready for market entry.
July 2015 | eMurmur awarded prestigious European Horizon 2020 research grant
The European Commission awards a prestigious EUR 50,000 Horizon 2020 grant to eMurmur to advance its R&D into a clinically tested mobile-based technology for the objective detection and classification of heart murmurs.
May 2015 | eMurmur wins Best of Biotech business plan competition
eMurmur wins the special MedTech award at the seventh international business plan competition "Best of Biotech". The competition awards excellence in the areas of life science and medical technology, is organised by Austria Wirtschaftsservice and commissioned by the Austrian Federal Ministry of Science, Research and Economy. A total of 30 projects with economic potential from six countries were selected by an international jury comprised of experts from the fields of industry, finance and economics. eMurmur was awarded a prestigious prize worth EUR 10,000.
Dec 2014 | eMurmur founded in Graz, Austria, and first round of angel investments
CSD Labs GmbH (d.b.a. eMurmur) was formally founded in Graz, Austria with the vision of leveraging state-of-the art signal processing, machine learning, and high quality clinical datasets to create an autonomous heart murmur detection AI. Additionally, eMurmur raises EUR 420,000 from US angel investors.
Jul 2013 | Founders receive prestigious Start-up grant from Austrian government
Founders Andreas Schriefl (PhD Physicist / Biomedical Engineer) and Andreas Reinisch (Computer Science & Biomedical Engineer) receive a prestigious start-up grant of EUR 210,000 from the Austrian government, rewarded to promising high-tech ideas with high-growth potential to allow for preliminary feasibility work on heart sound analysis and development of a business plan around the founders’ vision.