FDA clears AI software for heart murmur detection with digital stethoscopes
eMurmur, an Ontario-based artificial intelligence (AI) startup, has received U.S. Food and Drug Administration (FDA) clearance for its suite of algorithms designed to evaluate heart recordings captured by digital stethoscopes.
The newly approved offering, eMurmur Heart AI, was designed to detect both the presence and absence of heart murmurs. In addition, it can provide hemodynamic data that helps care teams as they develop patient management strategies. eMurmur Heart AI can be accessed through the company’s own standalone software—available as a web platform or mobile app—or through a third-party system.
“It has been our sole focus for years to develop the best and broadest auscultation AI out there,” Andreas Schriefli, PhD, eMurmur’s founder and CEO, said in a prepared statement. “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. This latest FDA clearance was a big milestone towards that goal.”
“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,” added Andreas Reinisch, eMurmur’s co-founder and chief technology officer. “With this clearance, we are excited to make our AI capabilities available to our partners as well.”
To date, eMurmur has secured three FDA clearances for its AI-enabled evaluations of heart and lung recordings. Back in 2019, for example, the FDA cleared eMurmur ID, a mobile and cloud offering that delivers AI-based analytics.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.