eMurmur announced that its flagship "eMurmur ID" solution has received the CE mark certification.
Accreditation is an important part of the eMurmur business, which now carries the quality management certification ISO 13485:2016 and the EC certification according to the Medical Devices Directive 93/42/EEC.
The news comes on the heels of eMurmur ID receiving FDA clearance, making it the only heart murmur detection solution that has received clearance for both the U.S. and European markets.
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 ML-based analytics, a mobile app, and a web portal. It supports the workflows of healthcare providers performing cardiac auscultation and has multiple applications including primary and specialty care, and corporate health.
Heart disease is the leading cause of death globally for both men and women, causing over 30% 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 that accuracy rates amongst primary care providers are low. With an accuracy rate of over 85%, eMurmur ID makes expert-level auscultation accessible to any healthcare provider performing auscultation.
The eMurmur ID technology has multiple areas of application including HMO networks, point of care clinics, executive health, pre-physicals, retail clinics, occupational health, rural health and telemedicine.
Founded in 2014 in Austria, eMurmur is a privately-held medical technology company specializing in machine learning for medical applications. eMurmur also provides heart-auscultation educational solutions. The company is based in Ottawa, Canada and Graz, Austria. It does business under the name eMurmur.
Source: Company Press Release