Stethee Pro 1
by M3DICINE Pty Ltd.
· Based in Australia →
— The World's First AI-Enabled Wireless Stethoscope System for Advanced Cardiac and Respiratory Diagnostics.
$499 (device); subscription for stethee central web portal
Regulatory Status Disclosed
Overview
The Stethee Pro 1, developed by M3DICINE Pty Ltd., is a revolutionary AI-enabled wireless digital stethoscope system designed for medical and healthcare professionals. It redefines traditional auscultation by allowing users to listen to heart and lung sounds with sophisticated amplification (up to 96x) and five proprietary filtering technologies, while also instantly capturing and analyzing vital sign data. Powered by its AI engine, ‘Aida,’ the system accurately measures systole, diastole, heart cycle durations, and respiration rate in as little as 20 seconds. Data is visualized in real-time through the Stethee Pro mobile app (iOS and Android) and the HIPAA-compliant Stethee Central Web Portal, enabling deeper insights, analysis, and secure sharing with colleagues or specialists. Beyond clinical data, Stethee Pro 1 automatically tags geo-location and environmental data, offering a new dimension for public health planning and understanding environmental impacts on cardiorespiratory health. It is designed to enhance clinical accuracy, improve workflow efficiency, and support remote care and telemedicine.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-enabled wireless digital stethoscope system
- Captures cardiac and respiratory vital signs in 20 seconds
- Measures systole, diastole, heart cycle durations, and respiration rate
- Sophisticated sound amplification (up to 96x) and 5 proprietary digital filters
- Real-time visualization of heart (PCG, AIDA Cycle, AIDA Energy) and lung sounds (spectrogram)
- Mobile app (iOS and Android) and HIPAA compliant Central Web Portal
- Secure data capture, analysis, recording, playback, and sharing capabilities
- Automatic geo-location and environmental data tagging (humidity, temperature, pollen count, pollution)
- Ambient noise cancellation technology
- EHR integration via PDF report generation and data import
Use Cases
- Medical screening and diagnostic examinations
- Monitoring of acute and chronic heart and lung conditions (e.g., heart failure, asthma, COPD, pneumonia, COVID-19)
- Telemedicine and remote patient health assessments
- Public health planning and environmental health impact analysis
- Enhancing clinical decision support at the point of care
- Medical research and education
What Physicians Need to Know
Arrhythmia Detection Support
The Stethee Pro 1 utilizes AI algorithms to analyze heart sounds, accurately measuring systole, diastole, and heart cycle durations in milliseconds. Its AI engine, Aida, can detect potential deviations and small shifts in the fundamental frequency of heart sounds, providing alerts and assisting in the management of certain arrhythmias.
Heart Failure Management Support
The device provides detailed insights into cardiac function and performance by capturing and displaying quantitative vital sign data, including heart rate and heart rate variability. This data helps clinicians establish comprehensive baselines and track the progression of cardiac conditions like heart failure.
Cardiac Monitoring Integration
Stethee Pro 1 is a wireless electronic stethoscope that connects via Bluetooth to dedicated iOS and Android mobile applications. Data is seamlessly transferred to the HIPAA-compliant M3DICINE Central Web Application, enabling secure recording, visualization, playback, and sharing of clinical data and patient reports with authorized providers. It supports remote health assessments and can import data into electronic medical records (EHR).
AHA/ACC Guideline Alignment
The Stethee Pro 1 system has received regulatory 510(k) clearance from the U.S. Food and Drug Administration (FDA), European authorities (CE), and the Therapeutic Goods Administration (TGA), affirming its compliance with established medical device standards.
Real-Time Alert Capability
The AI engine can alert users to small shifts in heart sound frequencies, and the companion app automatically detects potential deviations in heartbeat. The device features an LED ring that illuminates with the patient's heartbeat and changes colors based on data quality, offering immediate visual feedback.
Physician Tip
Leverage Stethee Pro 1 for objective and quantitative auscultation, moving beyond subjective assessments. Utilize its 20-second vital sign capture for efficient patient examinations and remote monitoring. The ability to record, visualize, and share heart and lung sounds, along with derived metrics like systole/diastole durations and heart rate variability, provides valuable data for tracking disease progression, supporting diagnostic decisions, and facilitating specialist consultations or teaching. Establish baselines for patients to monitor changes over time, enhancing personalized care.
Stethee Pro 1 integrates with iOS and Android mobile devices via Bluetooth, serving as the primary interface for data capture and initial analysis. The M3DICINE Central Web Application acts as a HIPAA-compliant cloud platform for comprehensive patient data management, report generation, and secure sharing among healthcare professionals. Its capability to import data into Electronic Health Records (EHR) streamlines workflow and ensures continuity of patient information.
Details
| Category | Cardiology AI, Wearables & Remote Monitoring (RPM) |
| Pricing |
$499 (device); subscription for stethee central web portal
|
| Deployment | Cloud-based (Stethee Central Web Portal) and mobile application (iOS/Android) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated M3DICINE received U.S. FDA regulatory 510(k) clearance (K193631) for its electronic stethoscope system, Stethee Pro 1, on October 9, 2020. It is cleared for medical screening and diagnostic purposes, detecting and amplifying sounds from the heart, lungs, arteries, veins, and other internal organs, and works with the Stethee Pro Software System to record, visualize, analyze, and share these sounds. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Emergency Medicine, Pulmonology |
Ratings & Reviews
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Press & Coverage
M3DICINE (Press Release)
M3DICINE Receives U.S. FDA Regulatory 510(k) Clearance for World's First AI-Enabled Wireless Stethoscope System for Cardiac and Respiratory Vital Signs Detection. Stethee Pro 1 System non-invasively captures cardiac and respiratory vital signs, providing data to aid in early detection of COVID-19* and other acute respiratory or cardiac conditions.
M3DICINE announced on December 8, 2020, that its Stethee Pro 1 electronic stethoscope system received 510(k) clearance from the U.S. FDA. This system is the first to be cleared with AI algorithms clinically validated to measure systole, diastole, heart cycle durations, and respiration rate in 20 seconds.
2020-12
Physician Ai Tools
Stethee Pro 1 AI Stethoscope for Physicians
The Stethee Pro 1 is an AI-enabled wireless digital stethoscope system that amplifies sounds up to 96x with five proprietary filters and instantly captures and analyzes vital sign data. It measures systole, diastole, heart cycle durations, and respiration rate in as little as 20 seconds, with data visualized via a mobile app and HIPAA-compliant web portal.
2026-04
FDA
K193631 - 510(k) Premarket Notification - FDA
This document is the FDA's 510(k) Premarket Notification for the Stethee Pro 1 and Stethee Pro Software System, submitted by M3Dicine Pty Ltd. It details the regulatory information and classification of the device as an electronic stethoscope.
2026-06
accessdata.fda.gov
October 9, 2020 M3DICINE Pty Ltd. Ginger Cantor Founder/Principal Consultant Centaur Consulting LLC W9281 710th Avenue River - accessdata.fda.gov
This 510(k) summary from October 9, 2020, outlines the Stethee Pro 1 as an electronic stethoscope for medical screening and diagnostic purposes, capable of detecting and amplifying sounds from various internal organs. It is intended for use with the Stethee Pro Software System for recording, playback, visualization, analysis, reporting, and sharing.
2020-10
Therapeutic Goods Administration (TGA)
M3DICINE Pty Ltd - Stethee Pro 1 System - Stethoscope, electronic (398131)
This entry from the Australian Register of Therapeutic Goods (ARTG) confirms the listing of the M3DICINE Pty Ltd - Stethee Pro 1 System as a Class IIa electronic stethoscope, with an ARTG ID of 398131, as of October 20, 2022.
2022-10
JACC: Advances
Artificial intelligence across the cardiovascular diagnostic pathway: a case-based narrative review - Abdalla
This narrative review, published in April 2026, discusses the role of AI in cardiovascular diagnostics, mentioning digital stethoscope and phonocardiography algorithms for scalable screening. It cites the FDA's 510(k) Summary for Stethee Pro 1 (K172296) from 2017 as a regulatory authorization for cardiovascular AI software.
2026-04
mHealth Spot
M3DICINE's Stethee is touted as the world's first AI-enabled stethoscope - mHealth Spot
Published in January 2018, this article introduces M3DICINE's Stethee as the world's first AI-enabled stethoscope system, including the FDA-cleared Stethee Pro. It highlights the device's ability to capture and analyze heart and lung sounds via Bluetooth to a mobile app, with its AI engine 'Aida' tagging geo-location and environmental data.
2018-01
SleepWorld Magazine
M3DICINE Introduces Stetheeu2122, the World's First AI-Enabled Stethoscope System
This January 2018 article announces the launch of M3DICINE's Stethee, the world's first AI-enabled stethoscope system, emphasizing its revolutionary design and ability to capture and analyze heart and lung sounds via Bluetooth to iOS or Android apps. It also mentions distribution agreements for Stethee Pro for telemedicine projects.
2018-01
Videos
Product demos, reviews, and walkthroughs for Stethee Pro 1.
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Frequently Asked Questions
The Stethee Pro 1 utilizes clinically validated AI algorithms to accurately measure cardiac vital signs like systole, diastole, and heart cycle durations in milliseconds, and respiration rate in just 20 seconds. It provides quantitative, standardized data and spectrogram views for lung function, aiding physicians in tracking disease progression and establishing patient baselines.
Yes, the Stethee Pro 1 System has received regulatory 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is also approved by European authorities (CE) for its AI-enabled system. The associated Stethee Pro mobile app and Central Web Portal are designed to be HIPAA compliant for secure data capture and sharing, with users agreeing to comply with applicable privacy laws including GDPR.
Stethee Pro 1 offers rapid, quantitative vital sign capture in 20 seconds, significantly reducing the subjective and time-consuming nature of traditional auscultation. While other AI-enabled stethoscopes like Eko Core and Thinklabs One also provide amplification and AI for murmur detection, Stethee Pro 1 is noted for its comprehensive cardiac and respiratory vital sign detection.
The Stethee Pro 1 System was available for $499 USD, often including a limited-time free subscription to its Central Web Portal. Advanced AI-driven analytics and insights are typically accessed through Stethee Central, which operates on a subscription-based model.
While Stethee Pro 1's AI is clinically validated for vital sign measurement, AI algorithms in healthcare generally face potential limitations such as data bias if training datasets do not adequately represent diverse patient populations. Studies on AI-augmented auscultation have shown improved sensitivity but sometimes reduced specificity compared to traditional methods, which could lead to an increase in false positives.
Yes, the Stethee Pro system is designed to integrate with existing Electronic Health Record (EHR) systems. It allows for the generation and saving of patient vital sign reports directly into EHRs, and data captured can be imported into patients' medical records from the Stethee Pro Central Web Portal and mobile applications.
Stethee Pro 1 is designed for practical use, aiming to simplify the capture of objective vital sign data and reduce the subjectivity often associated with traditional auscultation. While extensive formal training specifics are not widely detailed, the system's intuitive software and visual displays are intended to help clinicians interpret sounds and track changes effectively.
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| Last Verified: 2026-04-22 | First Added: 2026-04-22