Airmod

by Heroic Faith International  · Based in Taiwan → — A Revolutionary Solution for Real-Time Breathing Sound Monitoring
Anesthesiology Critical Care Pulmonology

Regulatory Status Disclosed

Overview

Airmod, developed by Heroic Faith International, is an innovative AI-powered software as medical device (SaMD) designed for continuous, non-invasive respiratory rate (RR) monitoring in adult patients undergoing procedural sedation and/or anesthesia. Operating as a mobile application on Android 10 and 11 devices, Airmod utilizes an AI-based algorithm to detect inhalation acoustics from an integrated AccurSound Electronic Stethoscope AS-101, which is placed on the patient’s neck.

The system converts respiratory sounds into visual spectrograms, providing real-time respiratory rates and timely alerts for potential breathing difficulties, including abnormal Partial Airway Obstruction (PAO) sounds. Airmod aims to significantly enhance patient safety by offering early detection of respiratory abnormalities, thereby reducing the risk of hypoxemia or oversedation during various medical procedures such as gastroscopy, colonoscopy, pediatric surgeries, plastic surgeries, and specialized dentistry. It features sophisticated ambient noise cancellation capabilities and a lightweight design, making it a valuable tool for healthcare professionals in hospitals and healthcare facilities legally credentialed to perform sedation and anesthesia.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based algorithm for respiratory rate detection
  • Continuous, non-invasive respiratory rate monitoring
  • Real-time detection of inhalation acoustics
  • Conversion of respiratory sounds into spectrograms
  • Timely alerts for breathing difficulties
  • Detection of abnormal Partial Airway Obstruction (PAO) sounds
  • Active noise cancellation
  • Lightweight patch/device
  • Android-based mobile application
  • Integration with AccurSound Electronic Stethoscope AS-101

Use Cases

  • Continuous respiratory monitoring during procedural sedation and/or anesthesia
  • Monitoring during gastroscopy and colonoscopy
  • Respiratory monitoring in pediatrics and plastic surgeries
  • Monitoring in pediatric and special needs dentistry
  • Early detection of abnormal respiratory rates in critical care settings (ICUs, emergency rooms, surgical theaters)
  • Monitoring for hypoxia and inadequate ventilation

What Physicians Need to Know

Key Capabilities
Airmod is an AI-powered respiratory monitoring device that converts respiratory sounds into spectra for interpretation, providing continuous, non-invasive monitoring of respiratory rate. It utilizes an FDA-cleared active noise cancellation electronic stethoscope (AccurSound AS-101) to filter out extraneous noise, focusing on clinically relevant breathing patterns. The system detects abnormal sounds indicative of partial airway obstruction (PAO) and provides continuous spectrogram display with timely alerts. It can also be used for home screening of airway collapse and potential sleep apnea.
Clinical Utility
Airmod significantly enhances patient safety during procedural sedation and anesthesia by offering early detection of airway obstruction and apnea, reducing the risk of hypoxemia or oversedation. It is particularly valuable in non-operating room anesthesia (NORA) settings, such as dental offices, endoscopy rooms, and ambulatory surgical centers. The device provides real-time visual monitoring of respiratory status and continuous recording of breath sounds, aiding timely interventions and improving the overall quality of respiratory care.
Integration Options
The Airmod system consists of the AccurSound AS-101 electronic stethoscope and the Airmod software, which is pre-installed in a high-performance interface device and is intended for Android-based devices. It operates via a cloud-based platform and can integrate with other medical equipment, such as professional blood oxygen monitoring devices, and AI airway collapse analysis services for comprehensive sleep monitoring.
Compliance Status
Airmod has received medical device regulatory clearance from the Taiwan FDA and obtained 510(k) Clearance from the US FDA in 2023. It is described as a non-invasive device with necessary safety certifications.
Pricing Model
Specific details regarding the pricing model (e.g., subscription, one-time purchase) are not publicly available in the provided search results. Interested parties are directed to contact Heroic Faith Medical Science for inquiries.
User Experience
The device is designed to be lightweight and easy to use. Its AI system effectively removes irrelevant ambient noises, speech, and equipment operation, ensuring that only clinically relevant breathing sounds are presented. The continuous spectrogram display and timely alerts contribute to a streamlined monitoring experience for healthcare professionals.
Implementation Complexity
Implementation involves deploying the AccurSound AS-101 electronic stethoscope with patches and integrating the Android-based Airmod software into existing clinical workflows. It is designed for use by credentialed healthcare professionals in hospitals and healthcare facilities performing procedural sedation/anesthesia.
Evidence Base
Airmod has been tested on over 13,000 patients in clinical practice and in over 150 hours of multi-center studies. It has been proven effective in non-procedural sedation and respiratory safety after testing on over 1,000 patients. The AI algorithm was trained using over 1.6 million breathing sound data entries, achieving an accuracy rate of up to 96%. Clinical studies indicate its performance is equivalent to capnography in respiratory rate and apnea detection, with a lower incidence of instrument failure. It is implemented in nearly half of Taiwan's medical centers and is being introduced in US dental training centers.
Physician Tip

Airmod offers a significant advancement in continuous respiratory monitoring, particularly for patients undergoing procedural sedation or anesthesia. Its ability to detect partial airway obstruction and apnea earlier than traditional methods like capnography can be critical for patient safety. Physicians should consider its application in NORA settings, where continuous, reliable respiratory monitoring can be challenging. The visual spectrogram and timely alerts can enhance team awareness and facilitate prompt intervention. For sleep-disordered breathing, its capability to assess airway collapse location provides valuable diagnostic information.

Airmod's core integration involves its proprietary AccurSound AS-101 electronic stethoscope and its Android-based software. Its cloud-based platform suggests potential for data sharing and integration with electronic health records (EHRs), though specific EHR integrations are not detailed. The mention of integration with blood oxygen monitoring and AI airway collapse analysis for sleep studies highlights its potential for a more comprehensive respiratory assessment ecosystem.

Details

Category Triage & ER/ICU AI, Wearables & Remote Monitoring (RPM)
Pricing Unknown
DeploymentMobile-app, cloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Airmod received 510(k) Clearance (K242798) from the U.S. FDA in 2023, classified as a Class II Breathing Frequency Monitor (Product Code BZQ), with a clearance date of February 28, 2025 for the K242798 submission.

Integrations
EHR Not specified
Specialties Anesthesiology, Critical Care, Pulmonology

What the Web Says

Airmod, developed by Heroic Faith Medical Science, is an AI-powered continuous respiratory monitoring system designed to enhance patient safety, particularly during procedural sedation and in non-operating room areas. It utilizes an active noise-canceling electronic stethoscope and AI to convert breathing sounds into spectrograms, detect abnormal breathing patterns, and provide real-time alerts to healthcare professionals. The device aims to overcome the limitations of traditional stethoscopes and capnography by offering continuous, interference-free monitoring and early detection of airway obstructions.

Overall: Positive

Strengths

  • Continuous, real-time respiratory monitoring.
  • AI-assisted interpretation of breathing sounds and timely alerts for abnormal events.
  • Active noise cancellation to filter out environmental sounds, focusing on clinically relevant breathing patterns.
  • Detects partial airway obstruction (PAO) and outperforms traditional auscultation and capnography in some aspects.
  • Lightweight, biocompatible patch for comfortable extended wear.
  • FDA 510(k) cleared in the U.S. and adopted in numerous medical centers in Taiwan.

Limitations

  • Primarily intended for Android-based devices only.
  • Limited information available from independent tech reviewers, G2, Capterra, or Reddit, making a comprehensive, unbiased assessment challenging.
  • The website mainly features testimonials and company-generated information, with a lack of diverse external reviews.
  • Specific pricing details are not readily available in the search results.
  • While FDA cleared, the extent of its adoption and long-term user experiences in the broader U.S. market are not extensively documented in the provided search results.
  • Some Reddit discussions about similar medical/tech products express general skepticism about online reviews and potential scams, though not directly about Airmod.

Based on reviews from: heroic-faith.com, PR Newswire, accessdata.fda.gov, Meet Global, CommonWealth Magazine, Hospitals Management, AiThority

Last updated: 2026-07-20

Ratings & Reviews

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Press & Coverage

PR Newswire
Saving Lives Through Communication, Heroic Faith Medical Science Showcasing Novel AI Auscultation Tool for Procedural Sedation Patients in PGA 77
Heroic Faith Medical Science's Airmod, an AI-powered auscultation tool with an electronic stethoscope, received Taiwan FDA medical device regulatory clearance and U.S. FDA 510(k) clearance in 2023. The system continuously monitors breathing sounds, visualizes data, and alerts healthcare professionals to airway obstruction or apnea, having been adopted in nearly half of Taiwan's medical centers.
2023-12
Taiwan Business TOPICS
Medical AI Progresses by Leaps and Bounds - Taiwan Business TOPICS
Heroic Faith Medical Science's Airmod, an AI-powered continuous breathing sound monitoring solution, gained Taiwan FDA approval in 2021 and U.S. FDA approval in March 2023. It is currently used in over 20 medical centers and is partnering with U.S. hospitals like Cleveland Clinic and Stanford University Medical Center for clinical trials.
2023-05
AAT World
Revolutionizing healthcare: Taiwan's medical AI innovations - AAT World
Heroic Faith's AI-based continuous breathing sound monitoring device, Airmod, alerts users of abnormal breathing situations in noisy environments, enhancing safety in procedures like dental and plastic surgeries. Airmod has FDA approval and is used by over 20 medical centers.
2023-08
Anesthesiology News
NEW PRODUCTS FOR YOUR PRACTICE - Anesthesiology News
Heroic Faith International Ltd. presents Airmod, a noninvasive respiratory monitoring system powered by Acoustic AI. It converts breathing sounds into real-time spectrograms, capturing subtle changes traditional monitors may miss, and features active noise cancellation for high-fidelity signals in noisy environments.
2026-06
PMC (PubMed Central)
Prediction of Arteriovenous Access Dysfunction by Mel Spectrogram-based Deep Learning Model - PMC
This peer-reviewed article details a study where Airmod software, in conjunction with an AccurSound AS101 electronic stethoscope, was used to convert audio signals of AV access sounds into Mel spectrograms for deep learning model development to predict arteriovenous access dysfunction. The CNN model based on Mel spectrograms showed promising results in predicting malfunctioning AV access.
2024-08
Innolitics
Airmod (K242798) u2014 FDA 510(k) - Innolitics
This FDA 510(k) premarket notification for Airmod, submitted by Heroic Faith International Ltd., details its classification as a Class II Breathing Frequency Monitor (21 CFR 868.2375). The document outlines Airmod's intended use as a software as a medical device for continuous, non-invasive respiratory rate monitoring in adult patients undergoing procedural sedation and/or anesthesia, for use with the AccurSound Electronic Stethoscope AS-101 on Android devices.
2025-02
ClinicalTrials.gov
Evaluation the Non-Inferiority of Airmod to Capnostreamu212235 on Respiratory Rate Monitoring and User Experience Clinical Evaluat - ClinicalTrials.gov
This clinical trial protocol outlines a study to evaluate the non-inferiority of Airmod to Capnostreamu212235 for respiratory rate monitoring and user experience in adult patients. Airmod is described as an investigational product designed for continuous non-invasive measurement and monitoring of respiratory rate by detecting inhalation acoustics and analyzing breathing sound signals.
2021-10
GeneOnline News
u89e3u6c7au8853u4e2du9ebbu9189u5b89u5168u96e3u984cuff1au807fu4fe1Airmod AI u807du8a3au6280u8853u7372FDA u8a31u53ef| GeneOnline News
Heroic Faith International Ltd. announced on April 17 that its Airmod respiratory monitoring software received U.S. FDA 510(k) clearance as a Class II software medical device. This certification validates the clinical effectiveness and safety of their AI-powered auscultation technology for continuous respiratory monitoring during procedural sedation.
2025-04

Videos

Product demos, reviews, and walkthroughs for Airmod.

View all on YouTube

Frequently Asked Questions

Airmod is an AI-powered respiratory monitoring device that uses an FDA-cleared electronic stethoscope to continuously monitor breathing sounds, converting them into visual spectrograms for real-time interpretation. It is designed to enhance patient safety during procedural sedation and anesthesia in non-operating room settings, such as endoscopy suites and dental offices, by providing timely alerts for breathing difficulties like partial airway obstruction.
Airmod, when used with the AccurSound Electronic Stethoscope AS-101, has received 510(k) Clearance from the U.S. FDA in 2023, classifying it as a Class II medical device. It also holds medical device regulatory clearance from the Taiwan FDA.
While Airmod is designed for continuous respiratory monitoring in sedated or anesthetized adult patients, it is not intended for use in non-sedated patients. The available information does not explicitly detail specific rates of false positives or negatives, but clinical trials are ongoing to evaluate its performance against existing monitoring standards.
Airmod offers continuous breathing sound monitoring, which traditional stethoscopes lack, and has demonstrated equivalence to capnography in respiratory rate and apnea detection. Notably, Airmod has shown a lower incidence of instrument failure during breath monitoring compared to traditional capnography, addressing some limitations of current methods.
Specific pricing details for Airmod are not publicly available. However, in the MedTech industry, pricing models are evolving to include value-based or pay-per-use structures, which could influence how institutions integrate the cost into their operational budgets and potentially offer flexibility based on utilization.
As an Android-based software medical device, Airmod would be subject to stringent data security and privacy regulations, including HIPAA in the U.S. HIPAA requires administrative, physical, and technical safeguards to protect electronic Protected Health Information (ePHI), encompassing risk analysis, access controls, and secure data handling.
Airmod is intended for use by healthcare professionals legally credentialed to perform procedural sedation and/or anesthesia. While specific training modules are not detailed, its usability has been assessed in clinical trials, suggesting a design that aims for straightforward integration into clinical practice.

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