Home / Clinical Decision Support & Reference / Tyto Insights for Wheeze Detection

Tyto Insights for Wheeze Detection

by Tyto Care · Based in Israel → — AI-powered decision support for remote respiratory assessment.

Allergy & Immunology Pediatrics Pulmonology

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Regulatory Status Disclosed

Overview

Tyto Insights for Wheeze Detection is an over-the-counter, artificial intelligence (AI) enabled decision support software system developed by Tyto Care. It is designed for the evaluation of lung sounds in adults and pediatrics aged 2 years and older. The software automatically analyzes the acoustic signal of the lung as recorded by a compatible FDA-cleared Tyto Stethoscope, identifying recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. This web-based system aids clinicians in the remote clinical assessment of lung auscultation data, enhancing diagnostic accuracy for respiratory conditions. It leverages TytoCare’s extensive database of lung sounds, the largest of its kind, to provide robust AI-driven insights. The tool is integrated into TytoCare’s Home and Pro Smart Clinic solutions, supporting both acute care and chronic condition management, such as asthma.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

AI-powered wheeze detection in lung sounds
Decision support for clinicians
Analyzes lung sounds recorded by compatible Tyto Stethoscope
Suitable for adults and pediatrics (2 years and older)
Web-based software system
Integrates with TytoCare's Home and Pro Smart Clinic solutions
Aids in remote diagnosis of respiratory conditions
Utilizes a large, proprietary database of lung sounds for AI training
Provides an indication to clinicians if wheezing is suspected
Supports chronic condition management, such as asthma

Use Cases

Remote diagnosis of respiratory conditions
Acute care management from home
Chronic condition management, particularly for asthma
Enhancing the quality and accuracy of virtual care
Supporting primary care and urgent care workflows
Alleviating challenges posed by healthcare professional shortages

What Physicians Need to Know

Evidence Base

Tyto Insights for Wheeze Detection is FDA-cleared (510(k) clearance in 2023) and also holds the CE Mark for use by clinicians in Europe (since 2022). It is built upon advanced algorithms, spectral analysis, and signal processing techniques that analyze recorded lung sounds. The development leveraged a large, proprietary database of anonymous clinical exam data from TytoCare visits, including lung and heart sounds, which is described as the largest of its kind. Clinical specialists, specifically pulmonologists, were integral in identifying and verifying abnormalities and pathologies within this dataset to train the AI algorithm.

Clinical Validation Studies

The algorithm underwent rigorous testing and validation to achieve FDA 510(k) clearance. Its performance and accuracy were evaluated using retrospective validation datasets derived from real-world use of the FDA-cleared Tyto Stethoscope. The algorithm demonstrated strong discriminative ability for detecting wheezes, crackles, and rhonchi, with an Area Under the Receiver Operating Characteristic curve (AUC) of 95.85%. This performance significantly outperformed general practitioners (79.45% AUC) and pulmonary experts (83.03% AUC) in detecting these lung sounds. Clinical validation confirmed that the device performs equivalently to, or better than, non-pulmonologist clinicians.

Alert Fatigue Management

While specific alert fatigue management strategies are not explicitly detailed, the system is designed to provide clear indications. It 'prompts a clinician if a specific abnormal lung sound suggestive of wheezing is suspected' and provides an 'indication on their Clinical Station' if wheezing is detected. For eligible US-based patients in the Asthma CCM solution, an indication is also provided in the TytoCare app. This flagging mechanism aims to highlight potential abnormalities for clinical review without overwhelming the user.

Override Rate Data

Not explicitly detailed in the provided information.

Differential Diagnosis Support

The tool provides objective and standardized detection of wheezing, a critical symptom for various respiratory conditions. Clinicians receive an indication of wheeze, which serves as a key input for their differential diagnosis process. However, the system emphasizes that clinicians should consider the device result 'in conjunction with other relevant exams and patient data' to make a comprehensive diagnosis and treatment decision. It acts as a 'specialist's/pulmonologist's second opinion' for lung sounds, enhancing diagnostic confidence.

Guideline Update Frequency

Not explicitly detailed; the AI algorithms are built on extensive clinical data and undergo rigorous FDA clearance, implying ongoing maintenance and updates, but a specific frequency for guideline integration or algorithm updates is not mentioned.

Clinical Workflow Integration

Tyto Insights for Wheeze Detection is seamlessly integrated into the TytoCare ecosystem, including the Home Smart Clinic and Pro Smart Clinic platforms. Patients perform lung exams using their Tyto device, and the AI algorithms automatically analyze the recordings. The clinician then receives an indication on their Clinical Station, facilitating remote diagnoses and supporting informed decision-making in virtual care settings. The system is designed for use in both primary care clinics and patient homes, with the AI algorithm activated during a lung exam within Tyto's digital stethoscope device.

Decision Audit Trail

Not explicitly detailed in the provided information.

Physician Tip

Leverage Tyto Insights for Wheeze Detection to gain objective and standardized wheeze detection, especially valuable in remote care scenarios and for enhancing diagnostic confidence. Always integrate the AI's findings with the complete clinical picture, including patient history, other physical exam findings, and contextual patient data, to formulate a comprehensive diagnosis and treatment plan. This tool is particularly useful for monitoring patients with chronic respiratory conditions like asthma and COPD, enabling timely interventions and reducing the need for unnecessary in-person visits. Remember that while the AI offers high accuracy, it serves as a decision support tool, and the final diagnosis rests with the clinician.

Tyto Insights for Wheeze Detection is a core component of the broader TytoCare platform, specifically enhancing the capabilities of the Home Smart Clinic and Pro Smart Clinic solutions. It processes acoustic data from the FDA-cleared Tyto Stethoscope and integrates with both the patient-facing TytoCare app and the clinician's Clinical Station, providing a unified virtual care experience. This integration expands TytoCare's chronic care management offerings and supports a holistic approach to remote respiratory care.

At a glance

Pricing Contact for pricing

Deployment Web Based Software System

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Details

Category	Clinical Decision Support & Reference, Wearables & Remote Monitoring (RPM)
Pricing	Contact for pricing Tyto Insights for Wheeze Detection software is automatically made available to existing TytoCare customers at no additional cost Pricing for the TytoCare platform and associated devices (e.g., TytoHome device for $299, TytoPro for clinicians at $999 plus a monthly subscription) is available upon contact
Deployment	Web-based software system
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated Tyto Insights for Wheeze Detection received FDA clearance (K232237) on December 13, 2023. It is cleared as an over-the-counter artificial intelligence (AI) enabled decision support software system for the evaluation of lung sounds in adults and pediatrics (2 years and older) when recorded by a compatible FDA-cleared Tyto Stethoscope.
Integrations
EHR	Not specified
Specialties	Allergy & Immunology, Pediatrics, Pulmonology

What the Web Says

Tyto Insights for Wheeze Detection is an FDA-cleared AI-powered software designed to assist clinicians in remotely detecting wheezing in adults and children aged two and older. It analyzes lung sounds recorded by the TytoCare handheld device, providing decision support to healthcare professionals. This technology aims to enhance virtual care by offering objective and standardized wheeze detection, potentially leading to more timely diagnoses and improved patient outcomes, especially for chronic respiratory conditions.

Overall: Positive

Strengths

FDA-cleared for wheeze detection in adults and children aged 2 and older.
Enhances virtual care by providing objective and standardized wheeze detection, aiding remote diagnoses.
Leverages advanced algorithms, spectral analysis, and signal processing techniques trained on a large database of lung sounds.
Can help prevent unnecessary emergency room visits and provide peace of mind for patients and parents.
Integrates seamlessly into existing clinical workflows for both live online visits and offline point-of-care.
Demonstrated strong discriminative ability in detecting wheeze, performing comparably to or better than non-pulmonologist clinicians.

Limitations

Not intended for use as a standalone diagnostic tool; a licensed healthcare professional's advice is required for interpretation and diagnosis.
Currently limited to patients aged two and older due to FDA clearance.
Requires a quiet environment for optimal sound recording and analysis.
Some users have reported negative experiences with the quality of virtual doctors provided through the broader TytoCare service, not specific to the wheeze detection AI.
The device itself cannot make a diagnosis; it only provides information for a healthcare provider to interpret.
Potential for degraded audio quality with hardware connections, though the Tyto system aims to mitigate this with in-built hardware and filtration software.

Based on reviews from: TIME, YouTube (Healthcare IT Today), TytoCare (tytocare.com), MedCity News, MemorialCare Innovation Fund, accessdata.fda.gov, Healio, OurCrowd, Reddit, Best Buy, GoodRx, PMC (PubMed Central)

Last updated: 2026-07-20

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Press & Coverage

RT (Respiratory Therapy) Magazine

FDA Clears AI Home Diagnostic Device for Respiratory Conditions

The FDA granted 510(k) clearance for TytoCare's Tyto Insights for Wheeze Detection, an AI-powered device that aids in the remote clinical assessment of lung sound data for adults and children aged 2 and older. This software analyzes lung sounds recorded by TytoCare's remote exam device to detect wheezing, strengthening its virtual primary care offerings.

2023-03

TytoCare

Tyto Insightsu2122ufe0f: Revolutionizing Wheeze Detection in Healthcare - TytoCare

Tyto Insights for Wheeze Detection is TytoCare's latest FDA-cleared, AI-powered decision support technology, designed to enhance virtual care by enabling standardized and objective detection of wheezing for timely, remote diagnoses. This solution is being rolled out to existing TytoCare customers at no additional cost starting in June 2023.

2023-03

Medical Product Outsourcing

TytoCare Gains FDA Clearance for Its AI Lung Crackle Detection

TytoCare received FDA clearance for its new AI-powered diagnostic capability, Tyto Insights for Crackle Detection, which complements its existing Tyto Insights for Wheeze Detection, cleared in 2023. This new tool helps clinicians detect lung crackles in adults and children over two years old during virtual visits.

2024-07

OurCrowd

FDA clears TytoCare's AI-powered lung sound analysis - OurCrowd

Tyto Insights for Wheeze Detection, which received a European CE mark in 2022, gained FDA clearance, enabling clinicians to remotely diagnose respiratory conditions. The AI-powered software analyzes lung sounds from TytoCare's remote examination device, alerting clinicians to wheezing in patients aged 2 and older.

2023-03

Healio

FDA-cleared AI-powered lung sound detection tool brings specialist to primary care, home

TytoCare's AI-powered Tyto Insights for Lung Sounds, which includes wheeze, crackle, and recently cleared rhonchi detection, aims to provide a specialist's opinion in primary care and home settings. The AI algorithm within the digital stethoscope assists in earlier diagnosis and treatment for conditions like asthma, COPD, bronchitis, and pneumonia.

2025-04

RT (Respiratory Therapy) Magazine

FDA Clears AI-Powered Tool for Detecting Lung Crackles in Virtual Visits

TytoCare announced FDA clearance for its AI-powered Tyto Insights for Crackle Detection, which complements the existing Tyto Insights for Wheeze Detection cleared in 2023. This new tool helps clinicians identify lung crackles in patients over two years old during virtual visits, enhancing the virtual clinic experience.

2024-07

StartupHub.ai

TytoCare Receives FDA Clearance for AI-Powered Wheeu2026 | StartupHub.ai

TytoCare received FDA clearance for its Tyto Insights for Wheeze Detection, an AI-powered technology that expands virtual primary care offerings by assisting in the remote clinical assessment of lung sound data for patients aged two and above. This technology leverages TytoCare's extensive database of lung sounds to provide accurate diagnoses of respiratory conditions.

2023-03

FDA

K232237 - 510(k) Premarket Notification - FDA

This is a 510(k) Premarket Notification document from the FDA for Tyto Insights for Wheeze Detection, submitted by Tyto Care, Ltd. The document details the regulatory classification and contact information for the applicant.

2026-04

Videos

Product demos, reviews, and walkthroughs for Tyto Insights for Wheeze Detection.

Tytocareu2019s AI-Powered Wheeze Detection Impresses with Thoughtful Design

Healthcare IT Today

Smoking & Lung Disease: Asthma, COPD, Emphysema Explained

MedHeads

Real Time Health Monotoring Device Market By Types: Wearable Devices & Home Health Medical Devices

Crystal Market Research

View all on YouTube

Frequently Asked Questions

How does Tyto Insights for Wheeze Detection integrate into my current clinical workflow, particularly for remote patient monitoring or telehealth?

Tyto Insights for Wheeze Detection is designed to be used with the TytoCare device, where patients conduct lung exams remotely. The AI algorithm automatically analyzes the lung sounds, and if wheezing is detected, an indication is sent to the clinician's Clinical Station, aiding in remote diagnosis and treatment decisions for respiratory conditions.

Is Tyto Insights for Wheeze Detection FDA-cleared, and how does it ensure patient data privacy and HIPAA compliance?

Yes, Tyto Insights for Wheeze Detection is FDA-cleared for aiding in the clinical assessment of lung sound data for adults and children aged two and above. To ensure data privacy and HIPAA compliance, AI tools in healthcare require robust encryption, access controls, and audit trails to safeguard sensitive patient information.

What are the primary alternatives to AI-powered wheeze detection, and how does Tyto Insights compare in terms of objectivity and accuracy?

Traditional wheeze detection relies mainly on auscultation with a stethoscope, which can be subjective and operator-dependent. While digital stethoscopes offer some improvements, Tyto Insights provides an objective and standardized method by automatically analyzing lung sounds, with its AI algorithm demonstrating higher accuracy than general practitioners and pulmonary experts in detection.

How is Tyto Insights for Wheeze Detection typically priced for healthcare providers or health systems?

Specific pricing for Tyto Insights is not publicly detailed, but healthcare AI solutions commonly use various models, including subscription fees, per-use pricing, or tiered compliance-based structures. The cost can also vary based on the solution's complexity, integration requirements, and whether it's part of a larger platform.

What are the known limitations or potential pitfalls of relying on AI for wheeze detection, and what role does the physician still play?

While AI can detect patterns, it lacks full medical context and cannot replace a professional diagnosis, potentially missing nuanced conditions or being influenced by biases in its training data. The physician's role remains crucial for comprehensive analysis, integrating AI insights with patient history and other clinical data to make the final diagnostic and treatment decisions.

How accurate and reliable is Tyto Insights for Wheeze Detection in identifying wheezing compared to a human clinician?

Tyto Insights for Wheeze Detection has demonstrated high accuracy, with its AI algorithm achieving an Area Under the Receiver Operating Characteristic Curve (AUC) of 95.85% for detecting wheezes, crackles, and rhonchi in clinical validation studies. This performance substantially outperformed general practitioners (79.45% AUC) and pulmonary experts (83.03% AUC). The system is trained on a large proprietary database of lung sound recordings to ensure reliability.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19