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Cardio.>Arrhytmia. 3D NonInvasive Loca-lization System.
Intended>ACQuisition, Analysis, Display
& storage of cardiac electro-
physiology data and maps for
analysis by a physician.
Intended>Used as Pre-Procedure>Planning
tool for patients with structu-
rally normal hearts undergoing
ablation treatment for idiopa-
thic ventricular arrhythmias.
System Consists of a hand-held 3D came-
ra, & an off-the-shelf laptop
computer with proprietary soft-
ware.
System Uses MRI or CT Scan along with a
standard 12-lead ΕCG to computer-
generate color-coded 3D mapping
images of the heart to indicate
the area of earliest activation.
Using a 3D photograph of the pa-
tient s chest, an MRI or CT
(DICOM image), and a standard 12-
lead ECG, the system generates a
3D rendering of the patient s
heart with superimposed color
coding to indicate the area of
earliest activation.
EU Approval Year : 2017.
USA Approval Date: 2019. 06.26.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 07.07.




Cardio.>Arrhytmia. Remote Diagnostics & Monitoring System that replicates in-hospital telemetry data, right in the office, by giving physicians 24/7 on-demand access to full disclosure Holter, Event, and MCT (Mobile Cardiac Teleme- try) data via a HIPAA-compliant portal APP.
EU Approval Date : 2014. 01.08.
USA Approval Date: 2016. 03.16.
(*) Companies; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 07.22.




Cardio.>ElectroPhysiology Device. Description: The non-invasive System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.
System aims to minimize noise and artifacts, and acquire high-fidelity cardiac signals. Improving cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures.
One of the most common reasons for an EP procedure is the diagnosis and treatment of atrial fibrillation. Atrial fibrilla- tion is the most common arrhythmia ..
USA Approval Date: 2018. 08.14.
(*) Company; Patent; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 10.14




Cardio.>Heart Failure (HF). Treat.: Cardiac Resynchronization Therapy (CRT).
Wireless Cardiac Pacing System.
Wireless Endocardial Pacing System.
Wireless Heart Stimulation.
EU Approval Date: 2015. 10.05.
(*) Company; Patents; Technology Trade
Mark & Web-Site Available on Request
UpDate: 2019. 09.01.




Cardio.>Implantable Cardiac Monitor (ICM) & Patient Alerting System for Acute Coronary Syndromes (ACSs.).
Implantation: Like Pacemaker in less
than 1 hour under local
anesthetic.
Indication : Patients have had prior
ACS events including
Myocardial Infarctions
(Heart Attacks) or
unstable Angina and who
remain at high risk for
recurrent ACS events.
EU Approval Date : 2010. 09.21.
USA Approval Date: 2018. 04.18.
(*) Company; Patents; TradeMark & Web-
Site Available on Request.
UpDate: 2019. 07.07.


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