FDA Clears eMurmur Heart AI Update for Murmur Detection Across Digital Stethoscopes

The U.S. Food and Drug Administration has cleared an updated version of eMurmur Heart AI, software that analyzes heart sounds recorded with digital stethoscopes to detect abnormal heart murmurs, the company said on January 29 in a press release from Ottawa.

The FDA's 510(k) database lists eMurmur Heart AI as K252284, a traditional 510(k) from applicant CSD Labs that was received on July 22, 2025 and found substantially equivalent on December 19, 2025. It is classified under 21 CFR 870.1875 with product code DQD, and the database records that a predetermined change control plan (PCCP) was authorized.

What was cleared

According to the clearance letter and 510(k) summary, the software is a decision support system for automated evaluation of recorded heart sounds. It identifies the first and second heart sounds, the presence of abnormal murmurs, and the absence of abnormal murmurs, which includes recordings with no murmur or an innocent murmur. Version 2.2 adds a feature that measures the average loudness of S1, systole, S2 and diastole and their loudness ratios.

The software takes a digital heart sound recording and the patient's age as inputs, runs on eMurmur's servers and returns results to the user's app. It is intended for pediatric and adult patients in settings where a health care provider can perform auscultation properly. The summary states that it is not intended as a sole means of diagnosis and that its interpretations are significant only alongside a provider's over-read and other patient data.

Under the PCCP, the list of supported stethoscopes may be extended without a new 510(k), the summary says. A software accessory, the eMurmur Transformer, provides compatibility with multiple stethoscope models.

Validation

The predicate is eMurmur's own earlier version, eMurmur Heart AI 1.0, cleared under K220766. The validation dataset combined the predicate's dataset with new, previously unseen recordings from pediatric and adult subjects, half with a confirmed abnormal murmur, with ground truth set by majority consensus of three board-certified cardiologists, the summary says.

Version 2.2 recorded sensitivity of 90.0% (95% confidence interval 78.8%-95.9%) and specificity of 90.0% (78.8%-95.9%), compared with 86.7% and 88.3% for version 1.0, and was shown to be non-inferior to the predicate, according to the document.

Company plans

The company said this is its third FDA clearance and that the update clears the AI for use with any supported stethoscope, making it an open platform for other companies' hardware and software. Customers can use it through eMurmur's own web and mobile apps or through an API integration.

“This latest FDA clearance was a big milestone towards that goal,” said founder and chief executive Andreas Schriefl, referring to the company's aim of building a hardware-agnostic AI layer. Co-founder and chief technology officer Andreas Reinisch said customers use the software for bedside auscultation, remote exams during virtual visits, pharmacy and community screenings and home health.