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The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from pediatric patients (aged 3 years and above) in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.

The AeviceMD is designed as an electronic stethoscope to acquire and record lung sounds from users for healthcare professionals (HCP) to playback and interpret the sounds recorded. AeviceMD does not contain any alarm feature and it is not intended for emergency use. It is also not a sleep apnea device. The device is not intended for self-diagnosis. The AeviceMD consists of hardware and embedded software. It is a five-part system that includes the following components: 1. **AeviceMD Sensor** – an embedded electronic wearable device that detects and records lung sounds and transmits data to an electronic gateway via Bluetooth. 2. **AeviceMD Silicone Patch** – silicone patch that houses and attaches the Sensor to the user's body (i.e., chest). This silicone patch undergoes biocompatibility testings which allow AeviceMD Sensor to be worn on the skin. 3. **AeviceMD Docking Station** – gateway device that serves as a computational hub and linkage from the Sensor to the Cloud Platform, and as a charger for the Sensor. 4. **AeviceMD App (for patients) / AeviceMD HCP Web App (for healthcare professionals)** - The AeviceMD App is a mobile app that downloads the post-processed information from the Cloud Platform and presents users with their recorded lung sounds at the auscultation locations which they can share with their HCP during their next consultation. A separate app, AeviceMD HCP Web App is tailored for HCP to review their patient's data in a clinical setting. 5. **AeviceMD Cloud Platform** – secure cloud server that receives data from gateway units and analyzes user's data using meaningful output information.

The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for long-term recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient's torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the AT-Report, and then a physician report is issued based on those results after a secondary analysis by a clinician or trained operator with experience in ECG analysis to correct any incorrectly detected events. The Physician report is offered to clinicians or physicians on an advisory basis only. The device is used by patients as prescribed by physicians or medical personnel. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.

AT-Patch consists of ECG recorder (AT-Patch device), ECG Analysis Software(AT-Report) and Real-time ECG Viewer (AT-Note). ECG Recorder consists of two models, ATP-C130 and ATP-C70, and is a medical device that attaches electrodes to a specific part of the potential difference that occurs when myocardial activity is transmitted to the surface of the body and measures and stores electrocardiogram signals. (ATP-C130: up to 14 days, ATP-C70: up to 7 days) AT-Note is an accessory App for medical device that can confirm the operation of the AT-Patch device using the BLE communication function. AT-Report is a medical device software that receives data stored in AT-Patch device using a Dedicated USB Cable and analyses it to provide information which is used to take decisions with diagnosis and can confirm the operation of AT-Patch device using the BLE communication function. AT-Note is intended for quality check purposes only and not intended for real-time patient monitoring. ECG analysis is performed only after data collection is completed.

The HiCardi+ H100 is intended to record symptomatic cardiac events and continuous electrocardiogram (ECG) for 72 hours from ambulatory patients by attaching HiCardi+ H100 SmartPatch to the skin surface. ECG records are stored in SmartPatch for review by the clinician after the recording period (up to 72 hours) is completed. It is indicated for use on 22 years or older who may be symptomatic and/or asymptomatic or suffer from transient symptoms as palpitations, shortness, of breath, dizziness, light-headedness, fatique, or anxiety. The reported ECG metrics include preliminary indications of the irreqular beat and/or rhythm and heart rate measurement based on a single-lead ECG basis. The arrhythmia information addressed in the report does not contain diagnostic interpretation; the reported indication is provided for review by the intended user to make a diagnosis based on clinical judgment and experience.

The HiCardi+ H100 consists of two components: - . Patient-worn ECG patch (Sensor, SmartPatch); - . Review & Report Generation Software (LiveStudio). The SmartPatch is a wearable and reusable patch device intended to measure ECG signals from a patient for 72 hours. The SmartPatch is intended to record ECG signals and automatically indicate the irregular beat and/or rhythm of the recorded ECG data to aid the clinician in finalizing the ECG interpretation. The SmartPatch has an Event Button the patient can press to record symptoms, such as heart palpitations, dizziness, or chest pain, etc. The LiveStudio is a review software operating on a personal computer (PC). The software visualizes the ECG data and preliminary indications from the SmartPatch for review, editing, and interpretation by the clinician. The LiveStudio provides tools to assist the clinician with their review. The final report includes the summary results of the review and can be documented by PDF formatted documents and printed by a printer connected to the PC.

S-Patch ExL wearable ECG patch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety. S-Patch ExL wearable ECG patch is intended for use by patients 18 years or older.

The S-Patch ExL ECG Patch System ("S-Patch ExL") is a light-weight electrocardiogram ("ECG") data collection device. The S-Patch ExL operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch ExL continuously acquires ECG signals and wirelessly transmits the data and via a smartphone application (that meets the definition of MDDS) to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified medical professionals. The S-Patch ExL does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.

ABPMpro Ambulatory Blood Pressure Recorder is a Non-Invasive oscillometric and ECG device intended to acquire Ambulatory non-invasive Blood Pressure signals and 3 Channel ECG signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. Additional physiological signals like plethysmogram, body position and activity are also measured. The Recorder is intended for adults and children who are over the age of 12 years. ABPMpro Software allows transfer of Blood Pressure-, ECG- and data from additional signals from the Recorder to a Windows-based PC-based computer program via USB cable for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostics evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.

The ABPMpro is a portable device for recording physiological signals. The ABPMpro is used as a long-term blood pressure as well as a long-term ECG device. The ABPMpro is a portable device worn on the upper arm by means of a cuff and used as an oscillometric 24h ambulatory blood pressure recorder. The ABPMpro consists of the following hardware: ABPMpro recorder with integrated accelerometer and position sensor; Brachial blood pressure cuff (3 sizes available); Optional: 3-channel ECG sensor; Optional: Plethysmogram-sensor (LED). Following the completion of the patient recording session, the device, cuff and electrodes are removed from the patient. The ABPMPro is connected to the PC using the USB cable. With the downloaded ABPMpro Analyzer Software open on the PC, the user can download the recorded data. The user can select the patient data and begin analysis. The device is intended for prescription use.

The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.

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The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor. It is intended to acquire, store and display ambulatory ECG signals from adult and pediatric patient. It is capable of measuring systolic and diastolic blood pressures of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are displayed and stored in the recorder. It is intended to be used by trained personnel under the direction of doctors.

Holter ECG and ABP System (Model: SA-20, SA-19, SA-18, SA-15, SA-16) is composed of the recorder, NIBP cuff, lead wire. The ambulatory blood pressure adopts the principle of the oscillometric method for non-invasive blood pressure measurement. ECG signals are obtained by placing electrodes on the patient's surface to record the potential change signal of the human heart and then processing the data to form an ECG waveform and store it in the Recorder to monitor the ECG signal.

S-Patch Ex wearable ECG patch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. S-Patch Ex wearable ECG patch is intended for use by patients 18 years or older.

The S-Patch Ex ECG Patch System ("S-Patch Ex") is a light-weight electrocardiogram ("ECG") data collection device. The S-Patch Ex operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch Ex continuously acquires ECG signals and wirelessly transmits the data and via a smartphone application (that meets the definition of MDDS) to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified medical professionals. The S-Patch Ex does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.

The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from adult patients in a clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.

The AeviceMD is designed as an electronic stethoscope to acquire and record lung sounds from users for healthcare professionals (HCP) to playback and interpret the sounds recorded. AeviceMD does not contain any alarm feature and it is not intended for emergency use. It is also not a sleep apnea device. The device is not intended for self-diagnosis. The AeviceMD consists of hardware and embedded software. It is a five-part system that includes the following components: 1. AeviceMD Sensor – an embedded electronic wearable device that detects and records lung sounds and transmits data to an electronic gateway via Bluetooth. 2. AeviceMD Silicone Patch - silicone patch that houses and attaches the Sensor to the user's body (i.e., chest). This silicone patch undergoes biocompatibility testings which allow AeviceMD Sensor to be worn on the skin. 3. AeviceMD Docking Station - gateway device that serves as a computational hub and linkage from the Sensor to the Cloud Platform, and as a charqer for the Sensor. 4. AeviceMD App (for patients) / AeviceMD HCP Web App (for healthcare professionals in a clinical setting) - The AeviceMD App is a mobile app that downloads the post-processed information from the Cloud Platform and presents users with their recorded lung sounds at the auscultation locations which they can share with their HCP during their next consultation. A separate app, AeviceMD HCP Web App is tailored for HCP to review their patient's data in a clinical setting. 5. AeviceMD Cloud Platform – secure cloud server that receives data from gateway units and analyzes user's data using meaningful output information.

The CardioSTAT ECG Test Solution is intended to capture, and report symptomatic and/or continuous ECG information for long-term ambulatory monitoring (up to 14 days). It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms, such as palpitations, shortness, lightheadedness, presyncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and thythm annotation. The report does not contain diagnostic interpretation; the report is provided for review to the intended user to render a diagnosis based on clinical judgment and experience.

The CardioSTAT® ECG Test Solution is a complete by prescription-only system for continuous ambulatory collection of ECG single-channel data for up to 14 days, followed by analysis and reporting of collected data. The CardioSTAT® ECG Test Solution is composed of two major components: (1) CardioSTAT® ECG Recorder and (2) ECG Analysis and Reporting Tool (EART) . The CardioSTAT® ECG Recorder (1) is a nonsterile, non-invasive, and single-patientuse recorder worn on the patient's torso that provides a continuous, single-channel, ECG recording for up to 14 days. The Recorder snaps onto two off-the-shelf FDAcleared long-term monitoring electrodes on which OFIX® adhesive tape is applied to ensure long-term adherence to the patient. After the prescribed recording duration, the device is taken off by the patient and mailed to the data analysis center for analysis where data is analyzed by Certified Cardiographic Technicians (CCT) using (2) ECG Analysis and Reporting Tool (EART). The EART is intended for use only by trained technicians. A clinical report is then sent to the physician. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the physician to render a diagnosis based on clinical judgment and experience. A home use kit (CardioSTAT® Home Application) is also offered which includes all required devices to allow for remote prescription and home application of the CardioSTAT® recorder. The included devices (surgical razor, alcohol prep pad, electrodes, OFIX® tape) outside of this submission are currently available on the market. The CardioSTAT® device is not designed to record ECG signals suitable to identify ST segment shifts and the EART software is not designed to detect or measure ST segment shifts. The ECG signal collected by the CardioSTAT® ECG Test Solution is not intended for automated analysis other than beat and noise detection. The ECG signal collected by the CardioSTAT® ECG Test Solution is not intended for third party ECG analysis systems. The CardioSTAT® recorder is not a real-time device and all clinical data is reviewed after the device has been returned to Icentia. The CardioSTAT® ECG Test Solution software provides automated detection of beats and noise only. All other classifications, rhythms and anomalies must be annotated by hand by the user in the EART software. Detections of beats and noise must be verified and confirmed by the user, or manually corrected with their respective annotation tools.