Austrian medical company eMurmur reported on Wednesday the receipt of CE mark certification for its flagship eMurmur ID technology to detect and classify heart murmurs with expert-level accuracy.
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.
The eMurmur ID technology has multiple applications including HMO networks, point of care clinics, executive health, pre-physicals, retail clinics, occupational health, rural health and telemedicine. Its early access programme is available at https://emurmur.com/clinical, designed to give early adopters full access to eMurmur ID.
eMurmur ID is a mobile and cloud solution which operates in conjunction with a third 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. It is comprised of ML-based analytics, a mobile app and a web portal.
According to the company, 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 CE mark follows eMurmur ID's recent US FDA clearance, making the device the only heart murmur detection solution that has received clearance for both the US and European markets.
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