FDA Clears AI-Powered Heart Murmur Detection Software

eMurmur has earned U.S. Food and Drug Administration 510(k) clearance for a suite of algorithms that can evaluate heart recordings captured by digital stethoscopes.

Heart AI suite is designed to deliver various outputs for improving heart health outcomes. Its artificial intelligence (AI) technology automatically identifies primary heart sounds (S1 and S2) and detects both the presence and absence of abnormal heart murmurs. Beyond murmur detection, eMurmur Heart AI delivers hemodynamic insights by calculating the energy of specific heart sound components, including S1, S2, systole, and diastole.

Besides more powerful AI capabilities, the FDA clearance enables the use of eMurmur Heart AI for any supported stethoscope—making it an open platform that can be integrated across different hardware and software solutions. The FDA clearance is eMurmur’s third such authorization.

“It has been our sole focus for years to develop the best and broadest auscultation AI out there. We see many new, innovative recording devices for heart and lung sounds entering the market, and made it our mission to build an open–hardware agnostic AI layer that can power them all,” eMurmur Founder/CEO Andreas Schriefl, Ph.D., said. “This latest FDA clearance was a big milestone towards that goal. We have now successfully created the first open auscultation intelligence layer that is cleared for use in the U.S. and EU.”

eMurmur delivers expert-level heart and lung sound analysis via its open platform design. Focused on building reach and accessibility, eMurmur reportedly is the only platform compatible with multiple stethoscope models. It runs across all major platforms—iOS, Android, web browsers—and can also be seamlessly integrated into third-party telehealth platform solutions. Using advanced engineering, eMurmur makes it possible for providers to screen, monitor, diagnose, and consult with greater certainty, according to the company. The technology elevates screening for heart, lung, and bowel health, and enables listening to the entire body with clarity highly appreciated by even the untrained ear. Using digital auscultation records, we enable enhanced diagnostic capabilities, whether delivering care in-person, remotely, at home, or asynchronously.

eMurmur Heart AI be accessed either through eMurmur’s standalone software or through secure API integration into third-party systems. The standalone solution is available as both a web application and a mobile app. For third-party integrators, eMurmur offers flexible options, ranging from AI analysis of heart and lung recordings to software interfaces to listen, record, and stream with high-fidelity.

“We are seeing a wide range of use cases among our customers, including bedside auscultation, remote stethoscope exams during virtual visits, pharmacy and community-based screenings, and home-health applications. With this clearance, we are excited to make our AI capabilities available to our partners as well,” eMurmur Co-Founder/Chief Technology Officer Andreas Reinisch said.

eMurmur is a technology partner to the global healthcare community, specializing in advanced digital auscultation. Supporting heart, lung, and bowel health, the company seeks to elevate the practice of auscultation in every interaction. eMurmur partners with hardware and telehealth providers to integrate high-definition auscultation technology into healthcare practice, whether delivering in-home, in-clinic, or virtual care. Using AI and advanced engineering, eMurmur and its partners make it possible for healthcare providers to screen, monitor, diagnose, and consult with greater certainty.