eMurmur has received FDA 510(k) clearance for its next-generation heart murmur detection software, eMurmur Heart AI (2.2).
The medtech company specializes in advanced digital auscultation technology and has offices in Graz, Austria and Ottawa, Ontario. The technology assists healthcare providers using digital stethoscopes in screening, monitoring and diagnosing abnormalities in the heart, bowel and lungs in pediatric and adult patients through its machine learning-based, end-to-end encrypted web portal and mobile app.
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In an interview eMurmur co-founder and CEO Dr. Andreas Schriefl said the auscultation software is designed to provide more objective analysis to a technique that relies on what providers hear, and assist physicians’ confidence in clinical decision-making, all in less time than traditional methods.
The updated software expands compatibility from just one digital stethoscope model to more and introduces a new feature that determines the loudness of individual heart sound components and their respective ratios. It also includes the same characteristics as the original version, such as detecting the presence or absence of abnormal heart murmurs, cases of no murmurs, innocent murmurs, and the detection of S1 and S2 heart sounds.
With the compatibility expansion, Schriefl said the clearance “unlocks the path” for his company — which he runs with co-founder and CTO Andreas Reinisch — to achieve its larger goals.
“It’s been our big goal to get to this point where we can really see the scale,” Schriefl said. “Our strategic goal is to become the AI layer to power all these cool, innovative hardware devices. We’re the only auscultation AI layer to date that you can integrate into your own software, into your own hardware.”
Schriefl’s vision to improve heart murmur detection with AI stemmed from a stressful experience that hit close to home. A family member’s one-month-old baby was diagnosed with a potentially pathological heart murmur after normal auscultation and referred to a specialist. The family waited weeks in between appointments, stressed about the possibility of a harmful murmur that turned out to be benign.
Inspired to create a more efficient way to detect heart murmurs, Schriefl brainstormed with medical professionals about the issues they faced with auscultation.
“We asked doctors who had to listen to newborns [and] they said, ‘It’s really hard to hear those murmurs. Is there a way to create a tool that could help us hear those?” Schriefl said. “And that’s what we have done.”
After receiving FDA approval on eMurmur Heart AI (1.0) in 2019, the technology was mostly used in a bedside setting. But during the early years of the COVID-19 pandemic, providers asked Schriefl if it was possible to use the software remotely during telehealth visits. His answer: yes.
“When you want to assess heart health, you can’t do this by video,” Schriefl said. “You need to listen. During COVID, we’ve expanded our software to also be able to listen remotely. That was the main driver for growth during that time. … We see healthcare networks set up remote clinics that are staffed with [nurses or technicians] trained with how to use peripherals like a blood pressure cuff or stethoscope. They can use us to connect them to someone qualified to do the listening, and combined with our interpretation, [it’s] what’s enabling us to serve these underserved areas with exams that wouldn’t normally be available to them.”
eMurmur’s latest FDA clearance allows the software to be integrated into customers’ existing software and hardware without needing additional FDA clearance, expanding eMurmur’s capabilities and impact.
Schriefl plans to launch the company’s lung auscultation software in the U.S. in the coming months and continue sharpening eMurmur Heart AI’s diagnostic technology.
“Within [the] heart, it’s going to get more specific over time,” Schriefl said. “We’re not just going to be able to say if you have an abnormal murmur or not, but what’s the underlying cause that creates the murmur.”
