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The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for continuous external electrocardiogram (ECG) information to support Holter Monitoring, Extended Holter Monitoring, and Outpatient Cardiac Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) monitoring. The SmartCardia 7L Platform is intended for: 1. Patients who experience transient symptoms that may suggest cardiac arrhythmia. 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath). 4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring. 5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports Measurements include: electrocardiogram (ECG signal), R-R interval, Heart Rate. Notification alerts can be set for one or more of these measures. The SmartCardia 7L Platform is indicated for use on patients who are 18 years of age or older to provide monitoring of physiological information. It is intended for use in a physician office, outpatient facility, or in the patient's home. SmartCardia 7L Platform contraindications: 1. The SmartCardia 7L Platform is contraindicated for use for detection of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. 2. The SmartCardia 7L Platform is contraindicated for use during external defibrillation.

The SmartCardia 7L Platform MCT is a body worn monitoring product that is designed with a disposable adhesive 7L Patch and reusable 7L Sensor. It is designed to be worn by the patient for up to 14 days. If longer monitoring is necessary, the 7L Patch is removed from the body, the 7L Sensor is removed from the worn 7L Patch which is discarded. The 7L Sensor is inserted into a new 7L Patch and the new assembly is placed on the patient for monitoring to continue. The 7L Sensor/7L Patch assembly communicates to the SmartCardia Phone via Bluetooth technology and shows the patient's heart rate and ECG on its display and allows the patient to input symptoms (Mark Event) which are shown in the patient record. The SmartCardia Phone has a medical grade mains powered charger and uses its cellular technology to act as a gateway to the SmartCardia Cloud Service provided by Amazon Web Services. The SmartCardia Phone is pre-configured by SmartCardia and placed in a kiosk mode. Data stored in the SmartCardia cloud can be viewed in the SmartCardia Web Browser application by a clinician or healthcare provider. The SmartCardia 7L Platform incorporates three modes of monitoring: 1. Holter Monitoring (up to 48 hours) and Extended Holter Monitoring (>48 hours and up to 14 days), 2. Event Monitoring (up to 48 hours, and >48 hours up to 14 days) 3. Cardiac Outpatient Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) (>48 hours up to 30 days when changing the 7L Patch) During any of the selected modes, a clinician or healthcare provider can use the SmartCardia Web Browser to view the continuously streaming patient's ECG. The SmartCardia 7L Platform provides alarm notifications for heart rate and atrial fibrillation. As stated in the Intended Use statement, the system is contraindicated for use in a critical care setting where an immediate response to life threatening conditions such as lethal arrhythmias is required. There are no alarm signals presented to the clinician for conditions other than heart rate and atrial fibrillation. The SmartCardia 7L Platform performs retrospective analysis and identifies events which it shows the clinician when they are reviewing historical data. The clinician must then review these events and determine if they are indeed valid and should be included in a physician's report. These events are things like "Ventricular Bigeminy', 'Supraventricular Couplet', etc. A full list is included in the Clinician Instructions for Use.

The Zio AT device is intended to capture and transmit symptomatic and asymptomatic cardiac events and record continuous electrocardiogram (ECG) data for long-term monitoring. 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, pre-syncope, syncope, fatigue, or anxiety. It is not intended for use on critical care patients.

The Zio AT® Electrocardiogram (ECG) Monitoring System is intended for continuous, long-term monitoring of a patient's ECG data with the ability to provide symptomatic and asymptomatic transmissions of potential arrhythmias during wear time. The Zio AT ECG Monitoring System enables ambulatory Mobile Cardiac Telemetry (MCT) services for non-critical care patients by providing the following devices for use. The Zio AT device consists of the Zio AT patch and Zio AT wireless gateway. The Zio AT patch is a single-use ECG monitor applied to the patient's chest, in-clinic or at home, and worn for up to 14 days without any required patient interaction for maintenance, such as replacing or charging a battery. The patch continuously records ECG data and transmits symptomatic and asymptomatic cardiac events through the Zio AT wireless gateway during the wear period. After the wear period concludes, the patient removes and returns the patch to the monitoring center, an Independent Diagnostic Testing Facility (IDTF), for analysis and end-of-wear reporting. The Zio AT wireless gateway securely receives ECG data from the Zio AT patch using Bluetooth technology. The gateway securely transmits ECG data through cellular technology for subsequent processing.

The RhythmStar system is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers all recorded cardiac activity to the cloud server where it is presented and can be retrospectively reviewed by a medical professional at a monitoring center. The RhythmStar system is not intended for real-time monitoring. The data received from the RhythmStar device can be used for retrospective review, arrhythmia analysis, and further evaluation, reporting and signal measurements using RhythmStar system or a compatible arrhythmia analysis software that has been FDA cleared for Lead II analysis using nontraditional wet electrode placement. The RhythmStar system is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, or provide for life support. The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician. RhythmStar is for prescription use only.

The RhythmStar system consists of the RhythmStar device and the server. The RhythmStar device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and autotriggered events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is capable of automatically delivering the collected ECG data to the server using a built-in 4G LTE wireless data modem, or the data can be transferred from the device using a USB connection. The data transmitted by the RhythmStar device can be stored, evaluated, and presented for review, analysis and reporting by a medical professional using a server, such as the RhvthmStar Svstem server.

The Now Cardio™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified healthcare professional for out-patient individuals with known non-lethal arrhythmias such as: - · Atrial Fibrillation - · Bradycardia - Tachycardia - · Pause It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the Now Cardio™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and transmitted ECG data are available to HealthCare Providers for analysis and reporting. Now Cardio™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.

The NowCardio™ System is a wearable, wireless arrhythmia detection system that provides continuous cardiac monitoring functionality for an extended period of up to 32 days. The NowCardio System is prescribed by healthcare providers to monitor, record, and report on a patient's electrocardiographic (ECG) data. The NowCardio™ system consists of: (1) a wearable electronic component that collects and monitors a patient's ECG data referred to as a NowCardio™ Sensor; (2) a custom cradle, referred to as the NowCardio™ Cradle, that is used to configure/charge the NowCardio™ Sensor in addition to providing ECG data download capability; and (3) a Remote Data Management System (RDMS) which is a remote server with software that will allow qualified healthcare providers to receive, analyze, interpret, and report on the results of the ECG test. The NowCardio™ System can be equipped with an optional Transmitter. The NowCardio™ Transmitter is used to transmit data acquired from the NowCardio™ Sensor to the RDMS as cardiac events are detected or patient triggered.

The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation. The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias. Conditions where the system should not be used include patients likely to experience primary Ventricular Fibrillation or Ventricular Tachycardia and patients who have other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening. The device has been validated for use on patients 6 years of age and older.

The MCT 3L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a patient alert buzzer. The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell phone. It has sufficient memory and processing capability to run the proprietary application. When an arrhythmia event is detected, the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center for professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone. The MCT 3L does contain software. The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.

The Zio QX ECG Monitoring System is intended to capture, analyze and report symptomatic and asymptomatic cardiac events and continuous electrocardiogram (ECG) information for long-term monitoring. While continuously recording patient ECG, both patient-triggered and automatically detected arrhythmia events are transmitted to a monitoring center for reporting. After wear, a final report is generated based on beat-to-beat information from the entire ECG recording. 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, pre-syncope, fatigue, or anxiety. The reports are provided for review by the intended user to render a diagnosis based on clinical judgment and experience. It is not intended for use on critical care patients.

The Zio® QX ECG Monitoring System consists of three key device components: (1) Zio QX Patch Recorder with Bluetooth technology, (2) Zio QX Wireless Gateway with both Bluetooth and cellular technology, and (3) the Zio ECG Utilization Service (ZEUS) System for data analysis and reporting. The Zio® QX Patch is a non-sterile, single-patient-use ECG monitor that provides a continuous, single-channel recording in addition to asymptomatic and symptomatic data transmission for up to 14 days. The Zio® QX Patch is applied and activated by the patient. Once activated, the Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. The Zio® QX Patch, in conjunction with the Wireless Gateway and the ZEUS System, has arrhythmia auto-detection capabilities. Additionally, patients have the option of pressing a convenient trigger button which marks the continuous record and initiates the wireless transfer of a 90-second ECG strip. The wireless transfer of data is enabled by the Zio® QX Gateway, which requires Bluetooth proximity to the Patch and cellular network reception but no patient interaction to transmit to the monitoring center. The patient is encouraged to document symptomatic events in either the provided booklet, mobile medical app (iOS 9+, Android 4.4+) or via a patient website, which will support symptom-rhythm correlation in the Zio QX Report. At the conclusion of the wear period (up to 14 days), the patient removes the Zio® QX Patch and returns it by mail to an iRhythm data processing center. Upon receipt of both symptomatic/asymptomatic transmissions (during wear) and downloaded continuous ECG data (post wear) at iRhythm's Clinical Center (iCC), the data is processed through the ZEUS detection algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm's Certified Cardiographic Technicians (CCTs) for accuracy. iRhythm employed and trained Patch in-take and CCT personnel follow internal procedures for processing and are made aware of performance limitations and anomalies with both the detection algorithms and software workflow tools. All anomalies are visible to and, where appropriate, are manually corrected by iRhythm Technologies CCTs during the QA review and/or Patch Report edits. The CCT generates a final report (Zio QX Report) of the ECG findings contained within the data, thereby providing a complete ECG processing and analysis service. Upon explicit request from a clinician responsible for the patient's healthcare, longer segments of ECG data from the continuous recording on the Patch can also be wirelessly retrieved during the wear period. Alternatively, such periods are also available for inclusion in the final report, where the entire ECG recording is available for review and selective inclusion based on clinical relevance.

MoMe® Kardia is intended to be used for: 1. Patients who experience transient symptoms that may suggest cardiac arrhythmia. 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath) 4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring. 5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. MoMe® Kardia is contraindicated for: 1. MoMe® Kardia is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias. Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

MoMe® Kardia is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. MoMe® Kardia includes the wearable MoMe® Kardia Device that acquires and stores ECG and motion (accelerometer) data and transmits that data via cellular technology to the MoMe® Software System (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. MoMe® Kardia requires no patient intervention to capture or analyze data however does provide a patient event trigger. MoMe® Kardia supports three cardiac monitoring modes: 1 Holter 2 Event Monitoring 3 Mobile Cardiac Telemetry (MCT) MoMe® Kardia: - Is non-invasive and poses no significant safety issues ● - Uses existing electrode and ECG technology ● - ls used in an adjunctive fashion, where physicians also use patient ● symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias. MoMe Kardia is not an emergency service. If the patient is experiencing symptoms that he/she is concerned about, the patient needs to seek immediate medical attention.

The MoMe™ Continuous ECG Monitor and Arrhythmia Detector System (MoMe™ System) is indicated for: 1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia. 2. Patients with dizziness or lightheadedness. 3. Patients with palpitations. 4. Patients with syncope of unknown etiology. 5. Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block. 6. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias. 7. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease. 8. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias. 9. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.

The MoMeTM Continuous ECG Monitor and Arrhythmia Detector System (abbreviated to MoMe System in this section) is a remote physiologic monitoring system that detects non-life threatening arrhythmias. The MoMeTM System incorporates a front end device worn by the patient that collects and streams ECG, heart rate and motion (activity) to a dedicated smartphone that continuously transmits the data to remote server. The system then uses proprietary algorithms to continually analyze data and provide reports of detected events. These reports can be accessed anytime, anywhere by a physician using a standard browser or a MoMe iPad App.

The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The NUVANT System monitors, derives and displays: - ECG - Heart Rate

The NUVANT MCT System consists primarily of the PiX monitoring device and the zLink data transmission device. Once activated, the wearable PiX sensor continuously monitors the heart and automatically collects ECGs. When rhythm abnormalities are detected, data are automatically transmitted from the PiiX device to the zLink, which then automatically transmits the data to the Corventis Monitoring Center. Patients can also trigger transmission of ECGs when they experience cardiac symptoms by using the Patient Trigger Button. Certified cardiographic technicians at the Corventis Monitoring Center review received data and document symptoms reported by patients. Clinical reports, prepared by the Corventis Monitoring Center, are delivered and made available at www.corventis.com to provide data to prescribing physicians for the diagnosis and identification of various clinical conditions, events and/or trends.

The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The NUVANT system model monitors, derives and displays: • ECG · Heart Rate

The NUVANT MCT System is a wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), NUVANT MCT enables arrhythmia detection for up to 7.5 days for each PiiX application. The NUVANT system components are: - PiiX® (aka: Adherent Device) a patient-worn device which is applied to the . patient's torso. It contains the ECG electrodes for recording ECG and heart rate data. - Patient Trigger Magnet used by the patient to manually trigger the ECG . collection when he/she experiences symptoms. - . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology. - Server The Server receives sensor data from the PiiX via zLink. ECG and . heart rate are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.