The FDA has cleared eMurmur ID, a software screening device that uses a smartphone, third-party digital stethoscope and machine learning to automate the detection of heart murmurs.
According to Ottawa, Canada-based eMurmur, the cloud tool identifies and classifies both dangerous and healthy heart murmurs, as well as the absence of a murmur and S1 or S2 heart sounds. The platform includes a mobile app, web portal and artificial intelligence analytics features, and is designed to fit into the workflow of healthcare providers. Recordings of heart sounds can also be securely shared with other experts for consultation.
“The evidence for its utility is solid and includes five studies on over 1000 patients, including blinded, multi-centre trials,” Dr. Derek Exner, a medical advisor at eMurmur and a professor and Canada Research Chair in cardiovascular clinical trials at the University of Calgary, said in a statement. “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.”
eMurmur received notice of the clearance on April 17, according to the FDA’s 510(k) database.
WHAT’S THE IMPACT
eMurmur’s tool promises to make consistent, “expert-level auscultation” available to healthcare providers regardless of their level of specialization. As such, the company believes that its tool could find a home in primary care practices, telemedicine consultations, employer health screenings and other settings poised for early detection of heart conditions.
WHAT’S THE TREND
A growing and diverse body of AI-based screening tools have received the FDA’s blessing over the past couple of years. Some of these include IDx’s autonomous diabetic retinopathy detection software, Bay Labs’ algorithm for reviewing echocardiography clip to calculate ejection fraction, and Zebra Medical Vision’s tool for measuring coronary artery calcification.
ON THE RECORD
“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,” Andreas Schriefl, co-founder and CEO of eMurmur, said in a statement. “We believe that eMurmur ID has the potential to disrupt the status-quo of heart murmur screening, save lives, improve patient care, and significantly reduce costs to healthcare systems worldwide.”