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DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.

The DeepRhythmAI is a cloud-based software utilizing CNN and transformer models for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration with other medical products. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices. The product supports downloading and analyzing data recorded in compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders used when assessment of the rhythm is necessary. The DRAI can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI doesn't have User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for the ECG visualization and analysis reporting.

DeepRhythmAl is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAl is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.

The DeepRhythmAl is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration with other medical products. The main component of DeepRhythmAl is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAl can be integrated into medical devices. The product supports downloading and analyzing data recorded in compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Outpatient Cardiac Telemetry devices or other similar recorders used when assessment of the rhythm is necessary. The DRAI can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl doesn't have User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for the ECG visualization and analysis reporting. DeepRhythmAl is not for use in life supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arthythmias using ECG data in adult patients. The product supports downloading and analyzing data recorded in compatible formats from 1-channel and 2-channel ambulatory ECG recording devices used for the arthythmia diagnostics such as Holter, event recorder or other similar devices when retrospective assessment of the rhythm is necessary. The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arthythmias. The DeepRhythm Platform utilizes DeepRhythmAl (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events. The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAI. The DeepRhythm Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.

The DeepRhythm Platform system is a cloud-based software with microservice architecture and browser-based user interface. It provides arrhythmia diagnosis process and monitoring session management capabilities. The DeepRhythm Platform's functionality consists of: - enrolling a patient for an ECG monitoring session in a medical facility (performed . by Healthcare Professionals users), - receiving the signal from a compatible monitoring device worn by the patient, . - using an external AI service for signal analysis and classification (not a part of the . subject device), - processing signal and annotations received from the external Al service, including . statistics computation, - · reviewing the signal and annotations by an ECG Technician user, - generating and publishing a report for a single ECG episode (Urgent report) and . for the entire monitoring session (End of Study report), performed by an ECG Technician user, - reviewing a published report back at the medical facility that ordered the monitoring . session in the first place (performed by a Physician user).

DeepRhythmAI is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Mobile Cardiac Telemetry or other similar devices when tof the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.

The DeepRhythmAl is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration with other medical products. The main component of DeepRhythmAl is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAl can be integrated into medical devices. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Mobile Cardiac Telemetry or other similar devices when the assessment of the rhythm is necessary. DeepRhythmAI can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl doesn't have a User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for the ECG visualization and analysis reporting. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. . DeepRhythmAI algorithm detects cardiac beats/arrythmias and intervals including: - . QRS - Heart rate determination - RR Interval measurements - Non-paced arrhythmias - Non-paced ventricular arrhythmia calls - Ventricular ectopic beats - Supraventricular ectopic beats DeepRhythmAl returns the interpretation result to be reviewed by a qualified healthcare professional. DeepRhythmAl when integrated with the other computer-based ECG systems, creates a semi-autonomous system for analysis of ECG recordings. All algorithm annotations must be analyzed and confirmed by a qualified healthcare professional. The subject device can only be integrated with the display product used by the monitoring center that allows for verification of the algorithm output, its correction and confirmation. DeepRhythmAl is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.

The Medicalgorithmics' Q Patch is intended to be used by patients who have a demonstrated need for extended cardiac monitoring and patients with symptoms that may be due to cardiac arrhythmias such as, dizziness, lightheadedness, shortness of breath, palpitations, dyspnea (shortness of breath), anxiety, syncope of unknown etiology in which arrhythmias are suspected or need to be excluded. It is indicated for use on adult patients. The sensor records single ECG channel for up to 15 days and can be used on patients with implanted pacemakers but is not intended to record pacemaker activity.

The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient's ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch's memory can be downloaded through a USB port using the Q Patch Downloader (PC application).

The PocketECG IV is intended to be used by: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. 2. 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). 3. Patients with palpitations without known arrhythmias to obtain a correlation of rhythm with symptoms. 4. Patients who require monitoring of the effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring. 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias. 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to arrial fibrillation or atrial flutter. Data from the device may be used by another device to analyze. measure or report OT interval. The device is not intended to sound any alarms for QT interval changes. Contraindications: The PocketECG IV is not intended to be used by: 1. Patients who have been diagnosed with life-threatening arrhythmias and require hospitalization. 2. Patients who require inpatient monitoring using a life-saving device.

The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV, type P4TR-AA-ADS is an ambulatory ECG monitor which analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities. All detection results, including annotations for every detected heart beat and the entire ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff.

PocketECG CRS is intended to be used for: 1. Cardiac monitoring of patients undergoing a cardiac rehabilitation program. Its main feature is patient monitoring during previously planned training sessions and training assistance to achieve desired intensity and duration of workout. Training session parameters such as heart rate threshold, session duration (time intervals and number of repetitions) are defined by the physician for each patient individually. Additionally, the transmitter allows continuous ECG monitoring between trainings, during patient daily activities. 2. All patients hospitalized with a primary diagnosis of an acute myocardial infarction (MI) or chronic stable angina (CSA), or who during hospitalization have undergone coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PCI), cardiac valve surgery, or cardiac transplantation, referred to an early outpatient cardiac rehabilitation or secondary prevention (CR) program. 3. All patients evaluated in an outpatient setting who within the past 12 months have experienced an acute myocardial infarction (MI), coronary artery bypass graft (CABG) surgery, a percutaneous coronary intervention (PCI), cardiac valve surgery, or cardiac transplantation, or who have chronic stable angina (CSA) and have not already participated in an early outpatient cardiac rehabilitation or secondary prevention (CR) program for the qualifying event or diagnosis, referred to such a program. 4. Patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and internittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease; 5. PocketECG CRS can be used to monitor the training session in hospital, rehabilitation center or physicians office under supervision of qualified staff.

Medicalgorithmics Unified Cardiac Rehabilitation System PocketECG CRS is an ambulatory system which can be used for patient monitoring during previously planned cardiac rehabilitation training sessions and training assistance to achieve desired intensity and duration of workout. The system measures patient's physical activity and ECG signal, classifies all detected heart beats and recognizes rhythm abnormalities. PocketECG CRS can be also used for patient's monitoring between training sessions as an ambulatory ECG monitor which analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities. All detection results, including annotations for every detected heart beats and the entire ECG signal are transmitted via cellular network to a remote server accessible by a Monitoring Center for review by trained medical staff.

The indications for use for the PocketECG III monitor are as follows: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs. PSVT) and ventricular ectopy: b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease; 2. 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); 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms; 4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation); 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring; 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias; 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter; 8. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes.

PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, type PECGT-IIIV is an ambulatory ECG monitor which analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities. All detection results, including annotations for every detected heart beat and the entire ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff.

The indications for use for the PocketECG v3 monitor are as follows: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease 2. 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) 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. 4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter. 8. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for OT interval changes.

PocketECG v3 - Medicalgorithmics Unified Arrhythmia Diagnostic System is an ambulatory ECG monitor which analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities. All detection results, including annotations for every detected heart beat and the entire ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff.