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MoMe® ARC is indicated 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® ARC is contraindicated for: 1. MoMe® ARC is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias. Note: MoMe® ARC does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.

MoMe® ARC 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. The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the MoMe® Software Platform (K152491) over a 4G LTE cellular link. The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway battery being wirelessly charged by the charging dock and the sensor battery being wirelessly charged by Gateway. The user interface is composed of a mechanical button, display with touch screen, vibrator, and a speaker on the Gateway and a vibrator and LED on the Sensor. The MoMe® ARC communicates with the MoMe® Software System (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. The MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. Once activated and operating normally the system requires no patient intervention to capture or analyze data. However, the MoMe® ARC has a patient triggered Event feature that allows for selection and recording of their symptoms if desired. The device is intended for use under prescription only for monitoring patients with suspected cardiac arrhythmias. MoMe® ARC: - 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® ARC 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 intended use of the MoMe® ARC is for ECG reporting and arrhythmia detection in patients with non-life threatening arrhythmias.

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® Software Platform is intended to be used for patients 22 years and older that have one or more of the following conditions: 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 MoMe® Software Platform is contraindicated for: 1. Patients with potentially life threatening arrhythmias who require in-patient monitoring. 2. Patients who the attending physician thinks should be hospitalized. 3. Patients with implanted pacemakers. ICDs, neurostimulators and/or body worn medical devices such as insulin pumps.

MoMe® Software Platform is a cloud based arrhythmia analysis and ECG management software system used for Arrhythmia Detection and Monitoring. The system receives ECG and optional activity data from single or multiple lead continuous ECG recorders over a local network or internet connection. This data is evaluated by an arrhythmia analysis algorithm when received, and any detected arrhythmias that the physician has elected to review are presented for physician review. The system provides information on arrhythmias detected, arrhythmia durations, activity levels, heart rate variability and patient reported symptoms. All full disclosure data, events and reports covering the patient monitoring period can be reviewed by a physician through web and mobile applications with secure, role-based authentication. The applications collectively provide for patient data entry, event review, creation of reports, and association of devices with patient records. The MoMe® Software Platform supports three cardiac monitoring modes: 1. Holter 2. Event Monitoring 3. Mobile Cardiac Telemetry (MCT) MoMe® Software Platform processes recorded cardiac monitoring data from ECG Devices that adhere to the data formats and communications protocol described in the Device Communications Protocol (10094), and may be reviewed at anytime, anywhere by a physician using a standard browser with web access. Data may also be exported for additional review and reporting if desired. MoMe® Software Platform is intended to provide information that assists the physician, along with patient symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias. MoMe® Software Platform 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.