Steth IO

by STRATOSCIENTIFIC  · Based in United States → — Personalized Remote Care in a Digital Age.
Cardiology Internal Medicine Pulmonology

Customized pricing; subscription-based for steth io spot.
Regulatory Status Disclosed

Overview

Steth IO, developed by STRATOSCIENTIFIC, is an innovative smartphone-powered stethoscope designed to modernize cardiovascular and respiratory examinations. It integrates a physical device that attaches to a smartphone with a dedicated mobile application, allowing healthcare providers to not only hear but also visualize heart and lung sounds in real-time as phonocardiograms or spectrograms. The system enhances diagnostic confidence by providing both auditory and visual data, aiding in the identification of abnormalities like cardiac murmurs.

Beyond traditional auscultation, Steth IO offers advanced telemedicine and remote patient monitoring capabilities. It enables secure recording and saving of patient exams, which can then be shared with specialists for review. The platform supports live auscultation during video calls, appointment scheduling, and patient notification for compliance, facilitating comprehensive continuous care. Steth IO incorporates digital filters to enhance sounds of interest and attenuate ambient noise, along with an annotation tool for detailed exam notes. It is an FDA-cleared Class II medical device, intended for use by healthcare providers in various clinical environments and for guided use by lay users in non-clinical settings for physical examination.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Smartphone-powered stethoscope hardware and app
  • Real-time visualization of heart and lung sounds (phonocardiogram/spectrogram)
  • Record and save patient exams
  • Share exams with specialists/other healthcare providers
  • Digital filters for sound enhancement and ambient noise attenuation
  • Annotation tool for adding notes to exams
  • Telemedicine capabilities (live auscultation, video calls, scheduling)
  • Remote patient monitoring
  • Assisted Intelligence (BETA) for algorithmic interpretation of phonocardiograms
  • Cloud-based system for data analysis and secure storage

Use Cases

  • Routine cardiovascular and respiratory examination in primary care settings
  • Teaching tool for medical students and residents
  • Reducing referrals for more complex investigations like echocardiography
  • Remote patient monitoring for management of chronic conditions
  • Telemedicine for episodic care and thorough patient evaluations
  • Streamlining clinical trial data collection and archiving patient records

What Physicians Need to Know

Abnormal Heart Sound Detection
Steth IO's AI tool assists in analyzing heart sounds, demonstrating an ability to accurately recognize abnormal heart sounds, such as murmurs, 73% of the time. This significantly improves upon the detection rates of traditional stethoscopes.
Early Cardiac Abnormality Identification
The technology aims to identify abnormalities during auscultation, such as cardiac murmurs, and facilitates early identification for timely adjustments in patient care. It has the potential to improve clinicians' abilities to diagnose heart and lung problems by combining visual and auditory signals.
Cardiac Monitoring Integration
Steth IO is designed for telehealth and remote patient monitoring, allowing patients to check vitals using their smartphone and securely share data directly with primary care providers or specialists. It supports real-time remote exams and enables the storage and organization of exams for future review and serial comparisons.
Real-Time Visualization & AI-Assisted Analysis
The smartphone application allows doctors to listen to, visualize, and record patients' heart sounds on iPhone devices, displaying them as a phonocardiogram in real-time. An 'Assisted Intelligence' feature automatically analyzes the exam sound file on a cloud-based system to aid in interpretation once a heart exam segment is completed.
Physician Tip

Steth IO serves as a valuable diagnostic aid, enhancing traditional auscultation by providing visual and AI-assisted analysis of heart and lung sounds. It is particularly useful for screening, remote patient monitoring, and potentially reducing the need for more complex investigations like echocardiography by improving early detection of cardiac abnormalities. Remember that the AI analysis is an assistive tool and should be confirmed with clinical examination.

The Steth IO system is an iOS-based smartphone stethoscope that integrates with an accompanying app, turning an iPhone into a smart stethoscope. It supports telehealth platforms, enabling secure data sharing with healthcare providers and facilitating live auscultation during telemedicine calls. The solution is designed for scalable, remote patient care that connects to any mobile device.

Details

Category Cardiology AI, Telehealth & Virtual Care, Wearables & Remote Monitoring (RPM)
Pricing Customized pricing; subscription-based for steth io spot.
  • Customized pricing for providers and clinics; Annual membership for Steth IO Spot: $15/month (includes 1 exam/month, first 3 months free with device purchase)
DeploymentMobile app, Cloud-based system.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 (K160016, cleared 07/15/2016) is intended for medical diagnostic purposes for the detection and amplification of heart and lung sounds with selective frequency ranges, tested for use on adults undergoing a physical assessment. Steth IO Spot (K220196, cleared 03/24/2022) is also an electronic stethoscope for amplification, filtering, and transmission of auscultation sound data.

Integrations
EHR Not specified
Specialties Cardiology, Internal Medicine, Pulmonology

What the Web Says

Steth IO is an FDA-cleared, iOS-based smartphone stethoscope that transforms an iPhone into a high-end stethoscope, allowing healthcare providers to hear, visualize, and record heart and lung sounds. It aims to improve diagnostic accuracy by combining auditory and visual signals, and it offers features like volume adjustment, real-time phonocardiogram visualization, and the ability to save and share exams. The device also incorporates an AI assistant to help doctors detect abnormal heart sounds, with reported accuracy significantly higher than traditional stethoscopes.

Overall: Positive

Strengths

  • Enhanced diagnostic accuracy through combined audio and visual data.
  • Ability to adjust volume, making it easier to detect subtle murmurs.
  • Real-time visualization of heart and lung sounds (phonocardiogram).
  • Recording and sharing of exams for specialist review and comparison over time.
  • Potential to improve telemedicine by enabling real-time remote examinations.
  • User-friendly and easy to adopt for healthcare professionals.

Limitations

  • Currently only available for iPhones, limiting accessibility for Android users.
  • Some features, including telehealth consultations, may require additional fees.
  • Limited extensive clinical studies compared to traditional methods.
  • Performance can slow down when connected to Chrome (though this might be referring to a different product also named Stetho).
  • Lack of robust community and user support compared to larger companies.
  • The AI assistant is not designed to make actual judgments about patient health, serving as a tool for a second opinion.

Based on reviews from: App Store (Apple), PCI-Lab, GeekWire, Accellabs, University of Washington, Steth IO, The World's Directory of Digital Health Apps, Devices & Innovations, YouTube, Telaspot

Last updated: 2026-07-22

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Press & Coverage

GeekWire
Steth IO launches smartphone-based stethoscope that visualizes heartbeats -- invented by teenager
Steth IO, co-founded by then 19-year-old Suman Mulumudi, launched its smartphone-based intelligent stethoscope that turns any iPhone into a smart stethoscope, helping doctors detect and diagnose heart problems by visualizing heartbeats. The device aims to improve diagnostic accuracy and potentially reduce healthcare costs associated with chronic heart disease.
2018-04
GeekWire
Steth IO raises $1.23M to expand smartphone-based intelligent stethoscope to new markets
StratoScientific, the Seattle-based startup behind Steth IO, raised $1.23 million from angel investors to expand the device's availability to the EU and Canada, and to fund clinical trials for specific cardiovascular conditions. The Steth IO is an iPhone case and app that allows users to hear, record, and visualize heartbeats.
2018-07
GeekWire
Smartphone stethoscope maker Steth IO launches AI assistant to help doctors detect heart problems
Steth IO launched an artificial intelligence tool to assist doctors in analyzing heart sounds, aiming to improve the detection of abnormal heart sounds, such as murmurs. The AI tool was trained using thousands of patient heart sound recordings and demonstrated a 73% accuracy in recognizing abnormal heart sounds.
2018-11
Steth IO
Steth IO News
Steth IO's news section highlights various updates, including supporting care teams during the Omicron variant, being featured on 'Worldwide Business with Kathy Irelandu00ae', and an embedded app partnership with Webex by Cisco. The company, founded in 2015, focuses on bringing medicine into the digital, connected age.
unknown
Innolitics
Steth IO (K160016) u2014 FDA 510(k)
Steth IO received FDA 510(k) clearance (K160016) on July 15, 2016, for its smartphone application software that performs real-time analysis, allowing users to hear and visualize heart and lung sounds. The device is intended as a diagnostic aid for healthcare providers to identify sounds and abnormalities.
2016-07
FDA
Steth IO Spot (K220196) u2014 FDA 510(k)
The Steth IO Spot received FDA 510(k) clearance (K220196) on March 24, 2022. This acoustic device with an integrated microphone attaches to a smartphone and collects biological sounds, which are then analyzed by the Steth IO Spot software telemedicine application.
2022-03
PMC (PubMed Central)
Biosensors for Personal Mobile Health: A System Architecture Perspective
This peer-reviewed article highlights Steth IO as an FDA-approved smartphone-based digital stethoscope comprising a smartphone case with a waveguide, a smartphone application, and a cloud platform for identifying abnormal heart and lung sounds. It discusses how the waveguide filters unwanted sounds and feeds amplified sounds to the smartphone's microphone for real-time phonocardiogram visualization.
2021-03
The AI Entrepreneurs
From Beats to Bytes: AI Stethoscopes Like Keikku Change the Game | The AI Entrepreneurs
This article from October 2024 discusses how AI stethoscopes are transforming healthcare, mentioning Steth IO as a device that integrates with smartphones to provide visual and audio feedback on heart and lung sounds. Its AI algorithms assist clinicians in diagnosing various cardiac and respiratory conditions.
2024-10

Videos

Product demos, reviews, and walkthroughs for Steth IO.

View all on YouTube

Frequently Asked Questions

Steth IO is an iOS-based smartphone stethoscope that allows physicians to listen to, visualize, and record heart and lung sounds on an iPhone. It incorporates an AI tool designed to assist in analyzing these sounds, particularly for detecting cardiac murmurs, serving as an assistive tool rather than a diagnostic one.
Yes, the Steth IO device is cleared by the FDA. Healthcare providers are responsible for ensuring their use of the application complies with all applicable laws and regulations, including HIPAA.
Steth IO's AI tool has demonstrated the ability to accurately recognize abnormal heart sounds 73% of the time, which is significantly higher than the approximately 20% accuracy reported for doctors using traditional stethoscopes. However, it is intended as an assistive tool to provide a 'second opinion' and not to make a definitive diagnosis.
The AI assistant is not designed to make an actual clinical judgment or diagnosis; it only assists the healthcare provider. Additionally, the device may be ineffective in hearing or visualizing biological sounds over thick garments or in individuals with a Body Mass Index (BMI) greater than 45.
The Steth IO Spot device is dispensed at $100, which includes free access to the full Steth IO telemedicine platform. For providers engaged in remote patient monitoring programs, RPM functionality can be added for $25 per patient per month, and the platform can qualify clinicians for RPM reimbursements.
Key competitors in the smart stethoscope market that offer AI-powered features include Eko Devices (Eko Health), Thinklabs, HD Medical, and M3dicine. Eko Health, for instance, provides digital stethoscopes with AI-powered murmur detection, real-time cardiac and pulmonary analysis, and telehealth integration.
Yes, Steth IO is designed to enhance telemedicine capabilities by enabling real-time remote exams with clinically significant data. Its platform integrates both telemedicine and remote patient monitoring features, aiming to simplify adaptation and deployment for healthcare providers.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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