Canadian medical technology firm eMurmur has secured the US Food and Drug Administration (FDA) clearance for its artificial intelligence (AI) powered mobile solution to detect heart murmurs.
Dubbed eMurmur ID, the mobile solution is intended for use with a third party electronic stethoscope.
It leverages machine learning to detect and categorise pathologic and innocent heart murmurs, the absence of a heart murmur, as well as S1, S2 heart sounds.
In addition to AI-based analytics and a mobile app, eMurmur ID consists of a web portal. The solution is believed to have applications in primary and specialty care, and corporate health.
eMurmur co-founder and CEO Andreas Schriefl said: “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.
“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.”
Heart disease, considered as the primary cause of death worldwide, is responsible for 31% of total deaths per year. The disease is commonly screened by listening with a stethoscope, called heart auscultation, for abnormal heart sounds or murmurs.
However, heart auscultation is known to be subjective and is said to have a low accuracy rate of 20%-25% in primary care.
The new solution is said to offer better auscultation, with an accuracy rate of more than 85%.
The solution has been assessed in five clinical studies involving a total of more than 1,000 patients.
Data showed that the automated heart murmur detection technology was accurate, informative and easy to use, offering a screening tool for confirming clinical diagnoses.