Tyto Insights for Crackles Detection

by Tyto Care  · Based in Israel → — Healthcare from anywhere, with no compromises
Family Medicine Pediatrics Pulmonology

Contact for pricing
Regulatory Status Disclosed

Overview

Tyto Insights for Crackles Detection is an FDA-cleared, AI-enabled decision support software system designed to analyze lung sounds in adults and pediatric patients aged two years and older. Developed by Tyto Care, the software automatically processes acoustic signals recorded by the compatible Tyto Stethoscope to identify and flag recordings where abnormal lung sounds suggestive of crackles are suspected.

The tool is designed for healthcare providers across primary care, urgent care, and remote patient monitoring settings. It is integrated directly into TytoCare’s Home Smart Clinic and Pro Smart Clinic solutions, enabling clinicians to perform comprehensive virtual respiratory exams.

Workflow Integration & Capabilities:

  • Acoustic Signal Analysis: Automatically evaluates lung sound recordings captured during remote physical exams.
  • Real-Time Flagging: Identifies and alerts clinicians to potential crackles in real time, serving as a diagnostic aid during virtual visits.
  • Clinical Decision Support: Provides an objective second opinion to assist clinicians in directing patients to appropriate follow-up care.
  • Seamless Integration: Operates alongside TytoCare’s broader AI respiratory suite, which also includes cleared algorithms for wheeze and rhonchi detection.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered crackle detection
  • Decision support for clinicians
  • Analyzes lung acoustic signals
  • Flags exams with potential abnormal sounds
  • Supports adults and children (2 years and older)
  • Integrated with TytoCare's Home Smart Clinic and Pro Smart Clinic solutions
  • Utilizes FDA-cleared compatible Tyto Stethoscope
  • Built on a large database of lung sound recordings
  • Real-time identification of crackles
  • Enhances diagnostic accuracy

Use Cases

  • Remote diagnosis of respiratory conditions
  • Virtual primary care visits
  • Virtual urgent care visits
  • Condition management (e.g., asthma)
  • School health programs
  • Worksite health programs

What Physicians Need to Know

Evidence Base
Tyto Insights for Crackles Detection received FDA clearance in 2024. It is built on TytoCare's proprietary database of 1.8 million lung sound recordings and leverages machine-learning algorithms trained and validated by pulmonologists.
Clinical Validation Studies
The software's performance and accuracy were evaluated using retrospective validation datasets from real-world use of the FDA-cleared compatible Tyto Stethoscope. The algorithm demonstrated strong discriminative ability for detecting wheeze, crackles, and rhonchi, with an Area Under the Receiver Operating Characteristic Curve (AUC) of 95.85%. This performance substantially outperformed general practitioners (79.45% AUC) and pulmonary experts (83.03% AUC). The tool is designed to help clinicians detect lung crackles in adults and children over two years old.
Alert Fatigue Management
When crackles are detected, the exam content is flagged, and providers are alerted to the presence of these abnormal lung sounds, aiming to enhance clinician efficiency and speed to diagnosis.
Differential Diagnosis Support
The tool identifies recordings suggestive of crackles, aiding healthcare providers in clinical decision-making by highlighting potential underlying lung conditions. It is not intended to detect other abnormal or normal lung sounds, and a licensed healthcare professional's advice is required to interpret the results. Providers should consider the device result in conjunction with other relevant patient data and factors before making a diagnosis.
Clinical Workflow Integration
Tyto Insights for Crackles Detection is integrated into TytoCare's Home Smart Clinic and Pro Smart Clinic solutions. It analyzes lung acoustic signals in real-time during virtual visits and flags potential abnormalities for clinical review, enabling faster and more accurate diagnoses and facilitating appropriate follow-up treatment.
Physician Tip

Physicians should utilize Tyto Insights for Crackles Detection as a decision support tool to enhance the efficiency and accuracy of lung sound assessment during virtual visits, particularly for adults and children over two years old. While the AI provides a highly accurate detection of crackles, it is crucial to integrate these findings with comprehensive patient history, other clinical signs, and additional diagnostic data to formulate a complete diagnosis and treatment plan. The tool serves as an 'extra set of eyes and ears' from a specialist perspective, but the final clinical judgment remains with the healthcare professional. Be aware that the tool specifically identifies crackles and does not interpret other lung sounds or provide differential diagnoses directly.

Tyto Insights for Crackles Detection is seamlessly integrated into TytoCare's Home Smart Clinic and Pro Smart Clinic solutions, working in conjunction with the FDA-cleared Tyto Stethoscope. This allows for real-time analysis of lung acoustic signals captured during virtual examinations, flagging abnormal findings directly within the existing TytoCare platform. This integration aims to streamline virtual respiratory care workflows and facilitate timely clinical review.

Details

Category Clinical Decision Support & Reference, Telehealth & Virtual Care
Pricing Contact for pricing
  • TytoHome device: $299; TytoPro (clinician version): $999 plus undisclosed monthly subscription; Tyto Insights for Crackles Detection is an integrated feature
DeploymentCloud
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Tyto Insights for Crackles Detection received FDA clearance (K240555) on July 2, 2024. It is an over-the-counter AI-enabled decision support software system used for evaluating lung sounds in adults and pediatrics (2 years and older), identifying recordings where crackles are suspected.

Integrations
EHR Not specified
Specialties Family Medicine, Pediatrics, Pulmonology

What the Web Says

Tyto Insights for Crackles Detection is an FDA-cleared AI-powered diagnostic tool designed to help clinicians detect lung crackles in adults and children over two years old during virtual visits. It is integrated into TytoCare's Home Smart Clinic and Pro Smart Clinic solutions, analyzing lung acoustic signals and flagging potential abnormalities for clinical review. The AI algorithm has demonstrated strong discriminative ability, performing equivalently to or better than non-pulmonologist clinicians in detecting crackles.

Overall: Mixed

Strengths

  • FDA-cleared for crackle detection in adults and children over 2 years old.
  • Enhances clinician efficiency and speed to diagnosis in virtual care settings.
  • Performs comparably to or better than non-pulmonologist clinicians in detecting crackles.
  • Integrates seamlessly into existing TytoCare Home Smart Clinic and Pro Smart Clinic platforms.
  • Aids in directing patients to appropriate follow-up treatment.
  • Part of a comprehensive AI lung sound suite that also detects wheezes and rhonchi.

Limitations

  • Requires a compatible Tyto Stethoscope for use.
  • Not intended to detect other abnormal or normal lung sounds beyond crackles (for this specific insight).
  • A licensed healthcare professional's advice is required to understand the meaning of the results.
  • Healthcare providers must consider the device result in conjunction with other relevant patient data.
  • No specific cons found regarding performance or user experience in the provided search results.

Last updated: 2026-07-19

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Press & Coverage

TytoCare Regulation
Tyto Insights for Crackles Detection has been cleared by the U.S. FDA.
Tyto Insights for Crackles Detection has received clearance from the U.S. FDA, demonstrating compliance with regulatory requirements. This is part of TytoCare's broader portfolio of FDA-cleared and listed devices.
unknown
PMC (PubMed Central)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
This peer-reviewed article from December 2025 details that 'Tyto Insights for Crackles Detection' (K240555) was cleared by the U.S. FDA in 2024 via the 510(k) pathway, utilizing a neural network for crackles detection in respiratory disease.
2025-12
Innolitics
The First AI Otoscope: What TytoCare's De Novo Means for AI in ENT
This article from April 2026 mentions that TytoCare's AI-enabled crackles detection (K240555) followed their Lung Sounds Analyzer and wheeze detection, indicating a strategic expansion of their AI-powered diagnostic tools.
2026-04
Exponent
Overcoming Limits for AI/ML Applications in the Life Sciences
Published in April 2025, this article describes 'Tyto Insights for Crackles Detection' (K240555, cleared July 2, 2024) as an over-the-counter, web-based AI-enabled software system designed to assist in the clinical assessment of lung sounds by identifying crackles.
2025-04
PLOS Digital Health
Evaluating few-shot prompting for spectrogram-based lung sound classification using a multimodal language model | PLOS Digital Health
A January 2026 research article references 'Tyto Insights for Crackles Detection' (2024) in the context of lung sound analysis and classification using multimodal large language models.
2026-01
accessdata.fda.gov
FDA 510(k) Clearance Letter for Tyto Insights for Crackles Detection (K240555)
The official FDA clearance letter from July 2, 2024, states that 'Tyto Insights for Crackles Detection' is an over-the-counter AI-enabled decision support software for evaluating lung sounds in adults and pediatrics (2 years and older), identifying recordings where a 'Crackle' is suspected.
2024-07
TytoCare
Future of AI Healthcare is here - TytoCare
TytoCare highlights its AI-powered Lung Suite, which includes Crackles Detection, as a groundbreaking feature for real-time identification of crackles in lung sounds to aid in detecting conditions like pneumonia.
unknown
MedTech Dive
Finding FDA authorized devices with Predetermined Change Control Plans
An August 2024 article lists 'Tyto Insights for Crackles Detection' with a clearance date of July 2, 2024, as an FDA-authorized device, categorized under Anesthesiology.
2024-08

Videos

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

View all on YouTube

Frequently Asked Questions

Tyto Insights seamlessly integrates with the TytoCare platform, analyzing lung sounds captured during a Tyto exam in both home and professional settings. It provides an AI-powered assessment to support your diagnostic process, flagging potential crackles for further review and aiding in more informed clinical decisions.
Yes, Tyto Insights for Crackles Detection received FDA clearance on July 30, 2024, for use in adults and children over two years old. It functions as an AI-enabled decision support software system to help clinicians detect lung crackles during virtual visits.
Tyto Insights operates within the secure TytoCare platform, which is designed with robust security measures. All patient data is encrypted and handled in strict adherence to HIPAA regulations and other applicable privacy standards.
While traditional auscultation relies on subjective human ear interpretation, Tyto Insights offers an objective, AI-driven analysis of lung sounds, potentially identifying subtle crackles more consistently. Clinical validation studies suggest TytoCare's AI algorithm can substantially outperform general practitioners and pulmonary experts in lung sound detection.
Pricing for Tyto Insights is generally part of the broader TytoCare platform subscription or service agreement, rather than a separate charge. Reimbursement for AI-assisted diagnostics is an evolving area, and coverage may vary based on specific CPT codes used for the TytoCare visit and individual payer policies.
Like all AI tools, Tyto Insights has inherent limitations; its accuracy can be influenced by factors such as ambient noise, patient cooperation, and proper device placement. While it shows good sensitivity, studies indicate challenges in achieving high specificity for crackles, suggesting it should be used as a supplementary decision support tool requiring physician interpretation.

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

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