SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION

Cardiology Internal Medicine Pediatrics

Contact for pricing
Regulatory Status Disclosed

Overview

The SensiCardiac Mobi Diagnostic Heart Murmur Application is an FDA-cleared electronic auscultatory device designed to assist physicians in the evaluation of patients’ heart sounds. It acquires, records, and analyzes acoustic heart signals captured via a compatible electronic stethoscope (user-provided). The system utilizes the Sensi Diagnostic Heart Murmur Algorithm, running on a hosted server environment, to distinguish between normal/physiological and pathological heart murmurs. The mobile application, compatible with devices like the iPhone 4S or later, facilitates data capture, display, and interaction with the hosted algorithm. It identifies specific heart sounds, including S1, S2, and suspected murmurs, recorded at the four main auscultation positions. SensiCardiac Mobi functions as a decision support software package and is not intended as a sole means of diagnosis, requiring physician over-read and consideration of all other relevant patient data.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Acquires and records acoustic heart signals
  • Analyzes heart sounds using the Sensi Diagnostic Heart Murmur Algorithm
  • Distinguishes between normal/physiological and pathological heart murmurs
  • Identifies S1, S2, and suspected murmurs
  • Records heart sounds at four main auscultation positions
  • Mobile application for data capture and display (e.g., iPhone 4S or later)
  • Requires a compatible electronic stethoscope (user-provided)
  • Operates as a decision support software, complementing physician assessment
  • High accuracy in heart sound analysis (e.g., 93% for abnormal sounds in a related context)
  • Hosted server environment for algorithm processing

Use Cases

  • Assisting physicians in heart auscultation
  • Evaluating patients' heart sounds for murmurs
  • Screening for pathological heart murmurs in clinical settings
  • Support for routine physical examinations (e.g., sports, school, occupational health)
  • Aid in diagnosing and treating problems before they become life-threatening
  • Especially useful for pediatric patients with high heart rates

What Physicians Need to Know

Heart Murmur Detection
The SensiCardiac Mobi Diagnostic Heart Murmur Application is a decision support system designed to acquire, record, and analyze heart sounds to identify specific heart sounds, including S1, S2, and suspected murmurs. It distinguishes between normal/physiological and pathological heart murmurs by analyzing acoustic heart signals captured with an electronic stethoscope.
Technology
The system comprises a mobile device (iPhone 4S or later), a hosted server environment running the Sensi Diagnostic Heart Murmur Algorithm, and a compatible electronic stethoscope (e.g., ThinkLabs Medical ds32a+). The mobile device acts as an interface for data capture, display, and patient information entry.
Clinical Accuracy
Clinical evidence includes bench testing and validation studies. A pediatric study reported 94% specificity and 84% sensitivity for heart murmur detection when validated against echocardiography.
FDA Authorization
The SensiCardiac Mobi Diagnostic Heart Murmur Application received FDA authorization (K131044) on September 4, 2013, as a Class II medical device.
Heart Sound Analysis
The application records acoustic heart signals at the four main auscultation positions. The Sensi Diagnostic Heart Murmur Algorithm analyzes these signals to identify S1, S2, and suspected murmurs.
Physician Tip

The SensiCardiac Mobi is intended as a decision support tool and not as a sole means of diagnosis. Interpretations of heart sounds should always be considered in conjunction with a physician's over-read and all other relevant patient data. The software is designed for use in a quiet environment on patients with audible heart sounds. It may not be suitable for use in noisy environments or on patients where auscultation is difficult, such as obese patients or those with pulmonary noise. Ensure a compatible electronic stethoscope is used, and for optimal performance with certain models like the Littmann 3200, use good quality headphones with a frequency range from 20 Hz to at least 10 kHz.

The SensiCardiac Mobi system integrates with a compatible electronic stethoscope (e.g., ThinkLabs Medical ds32a+) to capture acoustic heart signals. Data is transmitted via TCP/IP to a hosted server environment running the Sensi Diagnostic Heart Murmur Algorithm. The mobile application (iPhone 4S or later) facilitates electronic transfer of medical device data and displays medical device data.

Details

Category Cardiology AI, Clinical Decision Support & Reference
Pricing Contact for pricing
DeploymentHosted server environment (Linux OS) with a mobile application interface
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Pediatrics

What the Web Says

The SensiCardiac Mobi Diagnostic Heart Murmur Application is a decision support tool designed to assist physicians and trained personnel in evaluating heart sounds. It works by acquiring and recording acoustic heart signals via a compatible electronic stethoscope, then analyzing these signals to identify S1, S2, and suspected murmurs. The application is intended for use in clinical settings and is not a sole means of diagnosis, requiring physician over-read and consideration of other patient data.

Overall: Mixed

Strengths

  • Provides decision support for heart auscultation, improving accuracy and aiding in the identification of murmurs.
  • Records and stores heart sound recordings for further review and sharing with colleagues.
  • Utilizes a hosted server environment for analysis, with the mobile device serving as an interface for data capture and display.
  • Clinical validation and usability testing have been performed, with a pediatric study reporting 94% specificity and 84% sensitivity.
  • User interface adapted for mobile devices, with usability scoring over 4 out of 5 in testing.
  • Can be used in various physical examinations, such as sports physicals, pre-employment physicals, and routine check-ups.

Limitations

  • Not intended as a sole means of diagnosis; requires physician over-read and integration with other patient data.
  • Requires a compatible electronic stethoscope (e.g., ThinkLabs devices), and some stethoscopes like Littmann 3200 are not compatible with the older version.
  • Should not be used in noisy environments, as external noise can influence sound recording.
  • Not recommended for use on obese patients or patients with pulmonary noise where auscultation is difficult.
  • The information available is from 2013-2014, suggesting the product may not be actively reviewed or updated in recent years.

Based on reviews from: biospace.com, innolitics.com, fda.gov, emurmur.com, fdaconsultants.com, manuals.plus, merlot.org, thecardiologyadvisor.com

Last updated: 2026-10-29

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Press & Coverage

massdevice.com
FDA releases September 2013 510(k) approvals
The FDA released its 510(k) approvals for September 2013, which included the SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION by Diacoustic Medical Devices (Pty) Ltd.
2013-10
innolitics.com
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION K131044
This article details the SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION, a Class II medical device cleared by the FDA on September 4, 2013. It functions as a decision support system for heart auscultation, utilizing an electronic stethoscope to capture and analyze acoustic heart signals to identify S1, S2, and suspected murmurs.
2013-09
fda.gov
510(k) Premarket Notification K131044
The FDA's 510(k) Premarket Notification for the SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION by Diacoustic Medical Devices (Pty) Ltd. provides regulatory details, including the applicant information and classification product code.
2026-10
fdaconsultants.com
SensiCardiac Mobi Diagnostic Heart Murmur Application 510(k) Summary
This 510(k) summary outlines the SensiCardiac Mobi Diagnostic Heart Murmur Application, a decision support device designed to acquire, record, and analyze heart sounds to differentiate between normal/physiological and pathological heart murmurs. The document asserts that the SensiCardiac Mobi device is as safe and effective as its predicate device.
2013-03
physicianaitools.com
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION vs FEops HEARTguideTM
This comparison highlights the SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION as a tool for identifying heart murmurs by analyzing acoustic heart signals from a stethoscope, contrasting it with FEops HEARTguideTM, which focuses on pre-operative planning for structural heart interventions using AI and digital twins.
2026-04
physicianaitools.com
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION vs HealthCCSng
This article compares the SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION with HealthCCSng, another medical AI tool.
2026-07

Videos

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Frequently Asked Questions

The SensiCardiac Mobi application is designed to support physicians in evaluating heart sounds by acquiring, recording, and analyzing acoustic signals from the heart. It identifies specific heart sounds, including S1, S2, and suspected murmurs, helping to distinguish between normal/physiological and pathological heart murmurs.
The SensiCardiac Mobi Diagnostic Heart Murmur Application is FDA-cleared and intended for use in a clinical setting by a physician or trained personnel under a physician's orders. It is important to note that it is not intended as a sole means of diagnosis, and interpretations should always be used in conjunction with physician over-read and other relevant patient data.
The SensiCardiac Mobi is not a standalone diagnostic tool and requires physician over-read and consideration of all other relevant patient data for its interpretations to be significant. It is also not recommended for use in noisy environments, on obese patients, or patients with pulmonary noise, as these factors can influence the sound recording.
Yes, there are other AI-powered auscultation tools available, such as Eko's SENSORA® platform and eMurmur Heart AI. These alternatives also aim to assist in the detection and analysis of heart sounds and murmurs, with some offering additional features like ECG integration or lung sound analysis.
The SensiCardiac Mobi application requires payment for the software and registration on the SensiCardiac website to receive an activation code. The activation code is linked to the software's serial number and registration code, allowing registration on a limited number of computers. Specific pricing details are not publicly available and would likely require direct contact with the vendor.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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