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The Tyto Insights for Rhonchi Detection is a prescription-use artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Rhonchi" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the Tyto Insights for Rhonchi Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

The Tyto Insights for Rhonchi Detection is a web-based AI-enabled software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Rhonchi is detected within the recorded sound data. The Tyto Insights for Rhonchi Detection Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems: 1. The Tyto Insights for Rhonchi Detection Application Server (APS) communicates with the Tyto Insights for Rhonchi Detection Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. 2. The Tyto Insights for Rhonchi Detection Algorithm Server (ALS) receives an audio file as input and returns an analysis result of positive or negative regarding whether a Rhonchi was detected as output. 3. The Tyto Insights for Rhonchi Detection Web Server (WBS) provides a graphic indication whether a Rhonchi is detected in the recording. It can be utilized both in the patient and clinician side. All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network. The recordings from the compatible Tyto Stethoscope (K181612) are sent by the third-party point of care app to the clinician app through the telehealth server. The telehealth server sends the set of the lung sound recordings to the Tyto Insights for Rhonchi Detection web server using its dedicated API. The AI enabled algorithm runs automatically and returns a response for each audio file with the indication of rhonchi to the telehealth server which sends a response to both the clinician side and the patient side.

The Tyto Insights for Crackles Detection is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Crackle" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Crackles Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

The Tyto Insights for Crackles Detection is a web-based (AI) enabled software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Crackle is detected within the recorded sound data. The Tyto Insights for Crackles Detection Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems: - The Tyto Insights for Crackles Detection Application Server (APS) communicates with 1. the Tyto Insights for Crackles Detection Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. - The Tyto Insights for Crackles Detection Algorithm Server (ALS) receives an audio file 2. as input and returns an analysis result of positive or negative regarding whether a Crackles was detected as output. - The Tyto Insights for Crackles Detection Web Server (WBS) provides a graphic 3. indication whether a Crackles is detected in the recording. It can be utilized both in patient and clinician side. All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network.

The Tyto Insights for Wheeze Detection is an over the-counter artificial intelligence (Al) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.

The Tyto Insights for Wheeze Detection is a web-based (AI) enabled software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Wheeze is detected within the recorded sound data. The Tyto Insights for Wheeze Detection Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems: - 1. The Tyto Insights for Wheeze Detection Application Server (APS) communicates with the Tyto Insights for Wheeze Detection Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. - 2. The Tyto Insights for Wheeze Detection Algorithm Server (ALS) receives an audio file as input and returns an analysis result of positive or negative regarding whether a wheeze was detected as output. - The Tyto Insights for Wheeze Detection Web Server (WBS) provides a graphic 3. indication whether a wheeze is detected in the recording. It can be utilized both in patient and clinician side. All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network.

The TytoCare Lung Sounds Analyzer is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of "Wheeze" is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional's advice is required to understand the meaning of the TytoCare Lung Sounds Analyzer result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.

The TytoCare Lung Sounds Analyzer is a web-based software system designed to aid in the clinical assessment of lungs auscultation sound data by analyzing recorded lung sounds to determine whether a Wheeze is detected within the recorded sound data. The TytoCare Lung Sounds Analyzer Software is intended to process recordings from the FDA-cleared compatible Tyto Stethoscope (Tyto Stethoscope, K181612). The acquisition of the acoustic data (recordings) is carried out by a professional user in a clinical environment or by a lay- user in a non-medical environment, in compliance with the labeling of the Tyto Stethoscope. The system is composed of the following sub-systems: - 1. The TytoCare Lung Sounds Analyzer Application Server (APS) communicates with the TytoCare Lung Sounds Analyzer Algorithm Server (ALS) and implements an application programming interface (API) for communication with the telehealth server. - 2. The TytoCare Lung Sounds Analyzer Algorithm Server (ALS) receives an audio file as input and returns an analysis result of positive or negative regarding whether a wheeze was detected as output. - 3. The TytoCare Lung Sounds Analyzer Web Server (WBS) provides a graphic indication whether a wheeze is detected in the recording. It can be utilized both in patient and clinician side. All the software subsystems (servers and storage) are hosted in the cloud and communicate through IP network.

wheezo is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate in adults and children (2 years and older). A licensed health care professional's advice is required to understand the meaning and importance of the wheezo readings.

The Respiri wheezo WheezeRate Detector contains the following components (1) wheezo Sensing Device (2) wheezo App and (3) Secure cloud server. The wheezo transfers a user's breath sound data to the App using a Smart Device. The sound data is analysed in the alqorithm, which is integrated inside the App and runs on the Smart Device. It is a hand-held, battery-operated, computer-based, pulmonary sound detector that utilises microphones to acquire, amplify, filter, record and quantify the presence of wheezing. The breath sound is transferred using Bluetooth® technology to smartphone for detection and quantification of wheeze presence, expressed as wheeze rate. The wheezo samples breathing and ambient sounds, and streams the audio data wirelessly via Bluetooth SPP profile to a connected Smart Device Mobile App. It does not store any recorded data into persistent memory. The Mobile App, through user interaction, must perform the standard Bluetooth pairing process to the wheezo prior to use. Wheeze rate is calculated by the Mobile App using the audio data received from the sensing device. A remote device can connect to the wheezo Sensing Device via Standard Bluetooth. The device supports Bluetooth Serial Port Protocol (SPP) mode, where asynchronous serial packets are transported using Bluetooth RFCOMM protocol. When not paired, the sensing device will be in discoverable mode.

The SonoSentry™ WheezeRate™ Detector is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate™ in adults and children (2 years and older). WheezeRate™ represents the percentage of abnormal breath sound detected during the measurement time. A licensed health care professional's advice is required to understand the meaning and importance of the SonoSentry™ readings.

The SonoSentry™ WheezeRate™ Detector is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze breath sounds at the trachea for the presence of continuous adventitious breath sounds/CABS. The device calculates and outputs a WheezeRate™ based on the amount of abnormal breath sounds detected in a given time. The device is designed for use in adults and children (ages 2 years and older). The SonoSentry™ WheezeRate™ Detector consists of: - . An acoustic contact sensor - . An air-coupled electret microphone for ambient noise reiection module - LCD screen to display measurement results . - . 4 user buttons - . Signal conditioning and digitization PCB - Dedicated DSP . - . SDRAM memory - . Embedded software

The PulmoTrack TM 2020 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack TM 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds. The PulmoTrack TM 2020 is indicated for patient population above two years old

The PulmoTrackTM 2020 is a computer based electronic stethoscope that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays, printed reports and automated identification of lung sounds. The data transfer may be done via Bluetooth wireless communication.

The PERSONAL WHEEZOMETER™ is intended for quantifying the presence of wheezing. This device should be used under the direction of a physician or licensed healthcare professional for monitoring acoustic pulmonary functions.

The PERSONAL WHEEZOMETER™ ™ is a hand-held electronic measurement device that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea for the presence of wheczes. The device outputs a wheezerate score based on the amount of wheezing detected in a given time. The PERSONAL WHEEZOMETER™ (PW) is intended to be a home use version of the PulmoTrack® (K980878) and PulmoTrack model 2010 (WIM-PC) (k071955), providing wheeze-rate information for both home and clinical settings. The PERSONAL WHEEZOMETER™ device consists of: - An acoustic contact sensor - An air-coupled electret microphone for ambient noise rejection module. - LCD screen to display measurement results - 4 user buttons - Signal conditioning and digitization PCB - Dedicated DSP - SDRAM memory - Embedded software.

The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.

The WIM-PC™ is a computer based electronic stethoscope that utilizes two contact sensors simultaneously to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays and printed reports. The WIM-PCTM system consists of: Acoustic sensors (attached to the patient using adhesive pads), Sensor pod with a built-in dielectric microphone for ambient noise pick-up, Tension-sensitive respiration belt, A/D data acquisition device, USB cable and signal cable, Laptop PC unit with Data Analysis software.

The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds.

The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds. The VR Lung Electrosonograph is a non-invasive device consisting of three primary components: 1) Electronic stethoscopes designed to collect lung sounds via dermal contact with the human thorax; 2) a Digital Collection Module ("DCM") for the conversion of analog data to digital data; and 3) a mobile computer workstation to assist in processing, displaying, and/or storing recorded information. The VR Lung Electrosonograph is intended to be used by trained healthcare practitioners, and has been designed to accommodate most clinic, treatment center, or hospital settings. While the VR Lung Electrosonograph may aid in diagnosis, the device is not intended to be used as a diagnostic instrument.