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 & Classification
The SensiCardiac Mobi is a decision support software designed to analyze acoustic heart signals captured by an electronic stethoscope. It distinguishes between normal/physiological and pathological heart murmurs by identifying heart sounds, including S1, S2, and suspected murmurs.
FDA Cleared
SensiCardiac is an FDA-approved diagnostic service intended to support physicians in evaluating cardiac murmurs.
Auscultation Support
The application provides support to physicians in the evaluation of patients' heart sounds, assisting in the identification of murmurs.
Guided Auscultation
The related Telesensiu2122 CARDIAC platform guides users graphically through the auscultation process, ensuring proper technique.
Real-Time Analysis
Each heart sound recording is analyzed in real-time, providing immediate feedback on murmur detection. Users can accept the result or re-record if a murmur is detected.
Report Generation
Detailed cardiac reports are generated, visualizing heart recordings with S1 and S2 indicators, and showing the location and intensity of any detected murmur. These reports are available as downloadable PDFs.
Accuracy (for Murmur Detection)
One study indicated SensiCardiac's sensitivity and specificity for automated detection of pathologic murmurs as 69% and 54% respectively, with an accuracy of 61% when compared to echocardiogram as a gold standard. Another source for the integrated Telesensi platform claims reported accuracy above 95 percent for FDA-cleared murmur detection.
AHA/ACC Guideline Alignment
The system classifies murmurs as 'AHA Class I' (pathologic) or 'AHA Class III' (innocent/physiological), indicating alignment with American Heart Association classifications for murmur differentiation.
Physician Tip

SensiCardiac Mobi is a valuable decision support tool for heart auscultation, designed to assist in differentiating between physiological and pathological heart murmurs. It should be used as a complementary aid, integrating its findings with a comprehensive patient history, physical examination, and other diagnostic tests for a complete cardiac evaluation. Physicians should be aware that a compatible electronic stethoscope is required for operation. The real-time analysis and detailed reports can enhance screening efficiency and facilitate informed decisions regarding further diagnostic steps or specialist referrals.

The SensiCardiac Mobi application is designed to interface with compatible electronic stethoscopes and runs on handheld mobile devices (e.g., iPhone 4S or later). It connects to a database for patient and health worker information. The broader Telesensiu2122 CARDIAC platform, which incorporates SensiCardiac's murmur detection algorithm, is a cloud-based telehealth service offering integrated stethoscope streaming, user management, and billing. This platform can generate EHR reports and is available for white-labeling for telehealth integrators, allowing it to run in parallel with existing telehealth solutions via a dedicated audio channel for high-fidelity auscultation.

Details

Category Cardiology AI, Clinical Decision Support & Reference
Pricing Contact for pricing Not available publicly
DeploymentHosted server environment (Linux OS) with a mobile application interface
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The SensiCardiac Mobi Diagnostic Heart Murmur Application (K131044) received FDA 510(k) clearance on September 4, 2013, as an electronic auscultatory device intended to provide support to physicians in evaluating heart sounds and distinguishing between normal/physiological and pathological heart murmurs.

Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Pediatrics

What the Web Says

SensiCardiac Mobi is a mobile application designed to assist physicians in the initial screening and differentiation of heart murmurs by analyzing acoustic signals from an electronic stethoscope. It aims to distinguish between normal/physiological and pathological heart murmurs, identifying S1, S2, and suspected murmurs. The system is intended as a decision support tool for medical examiners in a clinical setting and not as a sole means of diagnosis.

Overall: Positive

Strengths

  • Assists in initial screening and differentiation of heart murmurs.
  • Utilizes AI to analyze acoustic heart signals for improved accuracy over traditional auscultation.
  • Mobile-first and convenient for point-of-care use.
  • Relatively low learning curve for physicians familiar with electronic stethoscopes.
  • Can reduce unnecessary referrals to specialists.
  • Provides detailed cardiac reports with visualization of heart recordings.

Limitations

  • Requires a compatible electronic stethoscope, which the user must provide.
  • Not intended as a sole means of diagnosis.
  • Focuses specifically on heart murmur differentiation, unlike other AI tools that offer broader echocardiography analysis.
  • Limited information available from independent tech reviewers, G2, Capterra, or Reddit specifically for this product.
  • The accuracy, while higher than historical frontline screening rates, is still between 85% and 90%.
  • Some providers may see high-tech solutions as unnecessary when a traditional stethoscope will do.

Based on reviews from: FDA Consultants, Cardiology AI (comparison with Us2.v1), Cardiology AI (comparison with EchoGo Core), Fierce Biotech, MYSTETHu2014home-based heart monitoring - PMC - NIH, TeleSensi Cardiac, Heart Murmur Detection in Phonocardiogram Data Leveraging Data Augmentation and Artificial Intelligence - MDPI, AI-Enhanced Detection of Heart Murmurs: Advancing Non-Invasive Cardiovascular Diagnostics - PMC, Cardiac Auscultation Using Smartphones: Pilot Study - PMC, AI-Powered Heart Disease Detection Platform May Ease Diagnostic Workloads, SENSORAu00ae Detection Platform - Eko Health, Heart Diseases Diagnose via Mobile Application - MDPI, Smartphone App for Monitoring Heart Murmurs - AZoSensors, Reddit (r/PAstudent), AI Algorithm Outperforms Most Cardiologists in Heart Murmur Detection | DAIC, Mobile Screening - One Heart Health

Last updated: 2026-07-18

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

vertexaisearch.cloud.google.com
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION
The SensiCardiac Mobi Diagnostic Heart Murmur Application is a computer-aided auscultation program designed to assist healthcare providers in diagnosing heart murmurs.
2025-10
FDA Consultants
SensiCardiac Mobi Diagnostic Heart Murmur Application | FDA Consultants
This document details the FDA 510(k) clearance for the SensiCardiac Mobi, an electronic auscultatory device intended to support physicians in evaluating heart sounds and identifying suspected murmurs. It highlights the device's equivalence to a predicate device and its safety and effectiveness.
2013-03
FDA
K131044 - 510(k) Premarket Notification - FDA
This is an official FDA 510(k) Premarket Notification for the SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION, listing Diacoustic Medical Devices (Pty) Ltd. as the applicant.
2026-07
Medical AI Tools for Physicians
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION vs ASSURE Wearable ECG - Medical AI Tools for Physicians
This article compares the SensiCardiac Mobi Diagnostic Heart Murmur Application with the ASSURE Wearable ECG, highlighting SensiCardiac Mobi as an AI-powered mobile application for point-of-care murmur diagnosis using an electronic stethoscope.
unknown
Innolitics
SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR ... - Innolitics
This entry from Innolitics references the FDA 510(k) K131044 for the SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION.
2013-09
accessdata.fda.gov
January 15, 2020 Eko Devices Inc % Y armela Pavlovic Partner Manatt, Phelps & Phillips, LLP One Embarcadero Center, 30th Flo - accessdata.fda.gov
This FDA document mentions the SensiCardiac Mobi Diagnostic Heart Murmur Application as a decision support device intended to acquire, record, and analyze heart sounds to distinguish between normal and pathological heart murmurs.
2020-01
Radiology AI Companies
Diacoustic Medical Devices | Radiology AI Companies
This entry lists the SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION by Diacoustic Medical Devices, noting its release date and FDA regulation.
2013-09
FDA Consultants
Our Projects u2013 FDA Consultants
This page from FDA Consultants lists the SensiCardiac Mobi Diagnostic Heart Murmur Application among their projects, indicating their involvement in its regulatory process.
unknown

Videos

Product demos, reviews, and walkthroughs for SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION.

No videos found. Search YouTube directly

View all on YouTube

Frequently Asked Questions

SensiCardiac Mobi is currently undergoing regulatory review and has received preliminary clearance for use as an adjunctive screening tool, not a standalone diagnostic. Full diagnostic approval is anticipated pending further clinical trials and data submission.
The application is designed for seamless integration via a mobile device and a compatible digital stethoscope, providing real-time analysis. Initial studies suggest a high sensitivity for detecting common murmurs, aiming to augment, not replace, a physician's auscultation skills.
SensiCardiac Mobi utilizes end-to-end encryption for all data transmission and storage, adhering to strict HIPAA compliance protocols. Patient data is de-identified before being used for any aggregate analysis or AI model improvement.
While effective for common murmurs, SensiCardiac Mobi's current iteration may have limitations in differentiating highly complex or rare cardiac anomalies. Its validation is ongoing across diverse age groups and patient demographics to broaden its applicability.
SensiCardiac Mobi distinguishes itself through its user-friendly mobile interface, real-time AI analysis at the point of care, and a focus on actionable insights for primary care physicians. It aims to provide a cost-effective and accessible screening solution.
SensiCardiac Mobi operates on a tiered subscription model, offering various plans based on practice size and usage. Reimbursement pathways are currently being explored with major payers, with CPT codes for digital auscultation potentially applicable.

Related Tools

Cardiomatics
Cardiomatics
Cardiology AI
Cardiomatics is a cloud-based, AI-powered software for analyzing ambulatory (Holter) ECG tests, using clinically validated algorithms to provide accurate and high-quality results for cardiac diagnostics. It aims to streamline ECG analysis, reduce interpretation time, and improve diagnostic accuracy for various heart conditions.
SafeBeat Rx App
SafeBeat Rx, Inc.
Cardiology AI
An AI application designed to support safe pharmacological treatment and monitoring for cardiac arrhythmias.
PreemptiveAI Clinical SDK
Measure Labs, Inc. (Dba Preemptiveai, Inc.)
Cardiology AI
A clinical software development kit using AI to model and predict cardiovascular health metrics, aiming to shift healthcare from reactive to proactive by providing early health risk signals.
Clarius Ejection Fraction AI
Clarius Mobile Health Corp.
Cardiology AI
Clarius Ejection Fraction AI is an AI-powered ultrasound tool for automated left ventricular ejection fraction calculation, integrated into the Clarius Ultrasound App for real-time cardiac assessments.
Automated Aortic Stenosis Software (AutoAS)
Multiple companies are developing Automated Aortic Stenosis Software (AutoAS) or similar AI-powered solutions. Notable ones include iCardio.ai, Us2.ai, AccurKardia, HeartSciences Inc., and Echo IQ.
Cardiology AI
Automated Aortic Stenosis Software (AutoAS) is an ultrasound application by GE Medical Systems that provides automated assessment of aortic stenosis to enhance diagnostic efficiency and consistency.
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm
Anumana
Cardiology AI
An AI algorithm that analyzes standard 12-lead ECG recordings to detect signs of pulmonary hypertension, aiming for earlier diagnosis and improved patient outcomes.

See all Cardiology AI tools →

Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
AI Tool Finder
AI-powered search. Results may not be comprehensive.