CAUTION: The law restricts these devices to sale by or on the order of a physician. After the procedure, parallel signal data samples will be harvested from all the systems using annotations and the time stamps as a guide. It recognizes software and service companies who demonstrate a commitment to helping provide more informed patient care.
CardioLab Recording Systems | GE HealthCare ComboLab provides the signal quality of CardioLab and interoperability of Mac-Lab on one platform. Contact Us.
Electrophysiology Recording System Cardiolab Xt Ep Once the signal data is harvested and organized, the signal samples across multiple procedures will be reviewed in a blinded, controlled fashion by 2-3 independent, unbiased expert electrophysiologist(s). 2023 Boston Scientific Corporation or its affiliates. ComboLab allows you to choose to use either the CardioLab* Electrophysiology Recording System or the Mac-Lab* Hemodynamic Recording System depending on your caseload.
When you need it. Communication Preferences. Used under trademark license. CardioLab Electrophysiology Recording Systems Where you need it. Comprehensive data collection at the point of care, Oeyvaersbosch 12 Europace. GE is a trademark of General Electric Company. The selection of the independent EP reviewers will also be done under the direction of the Principle Investigator. During the ablation procedures, annotations will be captured on the PURE EP system based on clinically relevant events defined in the protocol. Used under trademark license. CardioLab EP Recording System Essential functionality. GE is a trademark of General Electric Company. With mapping and ablation system data integration, an optional Centricity* CA1000 Workstation and more, CardioLab XT helps drive clinical throughput in high-speed, high-volume labs challenged . 2023 GE HealthCare. Optionally, CardioLab can also interface with third party X-ray systems. Exceptional performance. Essential functionality. Operate critical CardioLab functions in the procedure room via the GE IGS X-ray system tableside control unit. CardioLab XT is the central convergence point for images, waveforms and data from multiple sources, combined with a full array of innovative EP lab tools. More Cardiac Mapping and AblationProducts. Electrophysiology / RHYTHMIA Cardiac Mapping System / LABSYSTEM PRO.
CardioLab Recording Systems | GE HealthCare (United States) https://www.linkedin.com/company/gehealthcare/, https://www.youtube.com/user/gehealthcare. (UK Only) 0800-032-9201. Information provided by (Responsible Party): Enrolled and consented patients who are indicated for and receive an elective cardiac ablation procedure using the PURE EP 2 system for monitoring and collection of intracardiac electrogram signals. See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, LABSYSTEM PRO Indications, Safety and Warnings, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Excellent electrogram signal processing and analysis, Waveform export in a variety of raw and image formats (ASCII, Binary, JPG, and BMP), Enhancements to user interface for improved patient assessment, Dedicated clinical and technical specialists for support and training.
CardioLab Electrophysiology Recording System - GE Healthcare 9.99 1999.99. CardioLab Recording Systems - EP Recording - Categories. The collected signals will then undergo BLINDED, CONTROLLED evaluation by unbiased electrophysiologist reviewer(s) to determine whether the PURE EP signals provides additional or clearer diagnostic information. Prior to use, please see the complete Directions for Use for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operators Instructions. collect registry-specific data elements at the point of care. [TimeFrame:After the collection of signal samples from at least (5) subjects and until study completion], Indication for cardiac ablation treatment, contraindication to electrophysiology study or ablation, Enrollment in any other ongoing arrhythmia study protocol.
CardioLab Hemodynamic Recording System - GE Healthcare Find ordering information for the LABSYSTEM PRO electrophysiology (EP) recording system and accessories. Read Less 1800 659 465 (AUS) 0800 659 465 (NZ) Subscribe to Smartmail $name Benefits With ComboLab, enhanced levels of integration are designed to deliver: When you need it.
Cardiolab Electrophysiology Recording Systems | GE Healthcare | Bioz From software updates to preventative maintenance, our service program is designed to help protect your investment and ensure you get the most out of your LABSYSTEM PRO electrophysiology (EP) recordingsystem. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Talk with your doctor and family members or friends about deciding to join a study. GE is a trademark of General Electric Company.
510(k) Premarket Notification With the legacy of Prucka inside, CardioLab technology features include: CardioLab is configurable to help streamline workflow, with signal data analysis tools to help you evaluate administrative and clinical operations. All rights reserved. This powerful central server and a series of point-of-care workstations is designed to help reduce delay and redundant data entry. The PURE EP system signals will be monitored by the physician investigator and a company clinical representative to validate the PURE EP 2 system runs as intended based on the system manual and meets expected standards for displaying signals. With the legacy of Prucka Engineering inside, our suite of CardioLab products delivers the EP data and visualization you need for even the most complex cases. CardioLab helps make your life easier and your workflow smoother. CardioLab* provides efficient information integration to help drive clinical throughput in high-speed, high-volume labs. Request a rep to learn how RHYTHMIA HDx can bring unprecedented clarity to yourEPlab. CardioLab sends demographic data to and receives procedure information from GEs IGS X-ray system. ComboLab Electrophysiology and Hemodynamic Recording System, CardioLab Electrophysiology Recording System. K130626. There are several standard electrophysiology recording systems in use today, such as the commonly used GE/Prucka CardioLab recording system ("Prucka") which would benefit from additional features in order to improve the ability to record, discriminate and analyze signals from the heart. When you need it. Used under trademark license. GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. 8200 WEST TOWER AVE. MILWAUKEE, WI 53223. The existing recording/mapping system clocks will be synchronized to the PURE EP clock prior to each procedure. 2021 Jan 27;23(1):130-138. doi: 10.1093/europace/euaa194. Once the signal data is harvested, cleaned, and organized, the individual signal samples will be reviewed in a blinded, controlled fashion by a group of independent, unbiased electrophysiologist(s). Bioz Stars score: 86/100, based on 1 PubMed citations. For general information, Learn About Clinical Studies. Selected signal sample sets (from the same date and time stamp) will be separated in the survey and arranged in random order.
Invasive Cardiology | GE HealthCare (United States) And signal-processing algorithms that can help lead to diagnosis and treatment of even the most difficult cardiac conditions. After separating the nerve trunk and branches, 0.5-2 mA stimulation was given with the stimulating electrode to evoke EMG activity. This is particularly true when pacing the heart and when ablating abnormal myocardial tissue, components of the conduction system or epicardial structures. Registry form sets to support the ACC-NCDR registry data; collect data the way you want with custom forms data allows up to 5,000 user-defined fields to be configured for data entry; gather registry data at the point of care, helping to minimize post-procedure chart pulls; collect data the way you want with custom forms data allows up to 5,000 user-defined fields to be configured for data entry and. When you need it. ADT data received from CCW or third party brokers becomes part of the case. This powerful central server and a series of point-of-care workstations is designed to help reduce delay and redundant data entry.
The product designated as SpecialsLab is the same as the Mac-Lab System with .
PDF CardioLab - Medhold Medical LABSYSTEM PRO Indications, Safety and Warnings .ge-cdx-header-redesign__authentication-menu-container__register-btn{color: #640ACD !important; border: 1px solid #640ACD;} Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Electrophysiology Recording System EmPower Workflow. There are several standard electrophysiology recording systems in use today, such as the commonly used GE/Prucka CardioLab recording system ("Prucka") which would benefit from additional features in order to improve the ability to record, discriminate and analyze signals from the heart. All trademarks are property of their respective owners. This multi-center, prospective, non-randomized, observational study will involve at least five patients undergoing elective cardiac ablation procedure for tachycardias such as atrial fibrillation, atypical atrial flutter, ischemic ventricular tachycardia, or symptomatic premature ventricular contractions (PVCs). User defined macros that allow clinicians to define the case flow to their specified workflow streamlining data collection and providing a comprehensive procedure report, integrate and interface with GE and third-party systems. CardioLab, an EP Lab recording solution, delivers excellent signal designed to help optimize efficiency. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Intuitive controls at your fingertips. Essential functionality. Exceptional performance. The product will be available in the following configurations: Mac-Lab System, CardioLab System, SpecialsLab System, or a combination of both Mac-Lab and CardioLab marketed as the ComboLab System.
CardioLab EP Recording System - GE HealthCare (India) To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Schedule a Demo Request Quote CardioLab* provides efficient information integration to help drive clinical throughput in high-speed, high-volume labs.
CardioLab Electrophysiology Recording Systems - GE Healthcare Enhanced signal quality. California Transparency in Supply Chain Act, https://www.linkedin.com/company/gehealthcare/, https://www.youtube.com/user/gehealthcare. Systems are hemodynamic and electrophysiology (EP) recording systems. CardioLab* XT provides efficient information integration to help drive clinical throughput in high-speed, high-volume labs. Schedule a Demo Request Quote CardioLab helps make your life easier and your workflow smoother. Intended for healthcare professionals only. The CardioLab Electrophysiology recording system is designed to help you optimize your workflow, productivity and throughput. CardioLab Electrophysiology Recording Systems Where you need it. Rx only. LABSYSTEM PRO is a performance-driven electrophysiology recording system that allows access to your EP study data from any location, in or out of the lab. Used Under Trademark License. CardioLab is configurable to help streamline workflow, with signal data analysis tools to help you evaluate administrative and clinical operations; true bi-polar recordings with up to 224 inputs and 128 channels; powerful, advanced signal analysis algorithms help support your thought processes, streamline procedures, and enhance analysis and case documentation; obtain exceptional signal quality. Patient Review Mode ComboLab combines electrophysiology and hemodynamics in one powerful recording system. Find products, medical specialty information, and education opportunities.
Electrophysiology (EP) Recording System - LABSYSTEM PRO Where you need it. Applicant Contact. 2630 Aartselaar Contrast Media & Molecular Imaging Agents, .ge-cdx-header-redesign__authentication-menu-container__register-btn{color: #640ACD !important; border: 1px solid #640ACD;} See all our electrophysiology products that work with the RHYTHMIA HDx MappingSystem. Advanced algorithms provide enhanced signal fidelity to electrophysiology recording, helping better visualize small physiological signalsthat means visualization information is available when and where you need it.
.ge-cdx-header-redesign__authentication-menu-container__register-btn :hover {color: #410588;border: 1px solid #410588;} The signal survey will be created under the direction of the Principle Investigator. CardioLab* provides efficient information integration to help drive clinical throughput in high-speed, high-volume labs.
EP Recording System | GE Healthcare UK ComboLab combines electrophysiology and hemodynamics in one powerful recording system. Used under trademark license. Powerful advanced signal analysis tools including review scrolling, multi-leg calipers, advanced pace detection, simultaneous analysis of multiple activation times, and real-time mapping and trigger tools to help streamline procedures, and enhance analysis and case documentation; electronic signature helps to save time for document compliance and. 2023 GE HealthCare. Clinical software applications and connectivity. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Information not intended for use or distribution in France. CardioLab* XT provides efficient information integration to help drive clinical throughput in high-speed, high-volume labs. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Instructions for Downloading Viewers and Players, MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS. CardioLab* provides efficient information integration to help drive clinical throughput in high-speed, high-volume labs. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Interfaces are available for most ablation generators logging energy, impedance, time and temperature. export comprehensive data to GE and third-party registry and data management systems. Where you need it. comprehensive data collection at the point of care. EmPower Synchronization. LABSYSTEM PRO is a performance-driven electrophysiology recording system that allows access to your EP study data from any location, in or out of the lab. California Transparency in Supply Chain Act, https://www.linkedin.com/company/gehealthcare/, https://www.youtube.com/user/gehealthcare. Invasive Networking This powerful central server and a series of point-of-care workstations is designed to help reduce delay and redundant data entry. Contrast Media & Molecular Imaging Agents, Easily integrates into existing clinical workflows and IT environment, Improved clinical experience through communication across pathways and data, Secured data and privacy, no matter how many users or points of data entry, Streamlines documentation by incorporating DFR algorithm into your workflow, Next-generation digital amplifier enables crisp, quick evaluations, Combines electrophysiology and hemodynamics into one recording system.
CardioLab XT EP Recording System - GE HealthCare ZERO BIAS - scores, article reviews, protocol conditions and more. High-performance CLab II PlusTM amplifier delivers the quality signals needed for exceptional intracardiac and ECG recordings; streamline procedures. [TimeFrame:Throughout the cardiac ablation procedure], Assess the quality of the PURE EP 2 intracardiac signals when compared to existing recording and mapping systems as determined by controlled survey of blinded, independent expert electrophysiology reviewers. GE is a trademark of General Electric Company. Sorry, you need to enable JavaScript to visit this website. Keywords provided by BioSig Technologies, Inc.: Biospecimen Retention: Samples Without DNA. Note: If you need help accessing information in different file formats, see
This powerful central server and a series of point-of-care workstations is designed to help reduce delay and redundant data entry. To achieve effective outcomes without complications, it is vital that the recording system enables the recognition of clearly abnormal (scared myocardium) and normal electrical signals. Belgium. CardioLab Electrophysiology Recording System CardioLab, an EP Lab recording solution, delivers excellent signal designed to help optimize efficiency. Any person indicated and consented for an elective cardiac ablation procedure who is >18 years of age. You have reached the maximum number of saved studies (100). GE is a trademark of General Electric Company. https://www.linkedin.com/showcase/ge-healthcare-india/, https://www.youtube.com/@GEHealthCareIndiaYT. 2023 GE HealthCare. 2023 GE HealthCare. CardioLab XT is the central convergence point for images, waveforms and data from multiple sources, combined with a full array of innovative EP lab tools. .ge-cdx-header-redesign__authentication-menu-container__register-btn :hover {color: #410588;border: 1px solid #410588;}
Novel Cardiac Signal Processing System - Full Text View With mapping and ablation system data integration, an optional Centricity* CA1000 Workstation and more, CardioLab XT helps drive clinical throughput in high-speed, high-volume labs challenged . Delivers excellent signal quality with unique adaptive noise filtering and up to 160 intracardiac channels. With the legacy of Prucka Engineering inside, our suite of CardioLab products delivers the EP data and visualization you need for even the most complex cases.
EmPower Integration. ComboLab combines electrophysiology and hemodynamics in one powerful recording system. CardioLab, an EP Lab recording solution, delivers excellent signal designed to help optimize efficiency. The reviewer will be asked specific and identical questions relevant to each set of signal samples, but the individual samples will be separated and randomized across a full survey containing many different signal samples from many different procedures. GE Healthcare's cardiology solutions deliver insights and streamline administrative effort that help you focus on patient needsand not the process. The LABSYSTEM PRO V2.8 upgrade provides connectivity to the Medtronic Cryoconsole and the range of Philips Intellivue vitals monitors that enables visualization and consolidation of important procedural data in one place. The primary aim of this study is to further establish the safe and effective use of the PURE EP System during cardiac ablation in the EP Laboratory in a post-market environment. After the procedures, parallel signal data samples will be harvested from all the systems using the procedure annotations and the time stamps as a guide. With the legacy of Prucka Engineering inside, CardioLab can deliver the EP data and visualization you need, where you need it, when it needs to be there.
PDF 3ia0(o 8 Fs - Food and Drug Administration At the beginning of the procedures, all systems will be optimized for best signal display based on the physician preference. CardioLab* provides efficient information integration to help drive clinical throughput in high-speed, high-volume labs. Bringing high quality products, services & innovations to the healthcare community.
CardioLab XT EP Recording System - GE HealthCare (India) The sample survey will be created under the direction of the PI. Get clear data delivered seamlessly. CardioLab offers innovative capabilities and functionality to deliver a system that is easy to use and customized to your workflow, while maintaining a strong focus on comprehensive IT data integration, interoperability between systems, excellent signal quality and solutions and the evolving requirements of cybersecurity. With mapping and ablation system data integration, an optional Centricity* CA1000 Workstation and more, CardioLab XT helps drive clinical throughput in high-speed, high-volume labs challenged to deliver excellent patient outcomes and maximum end-to-end efficiency. The recording electrode was inserted into one end of the target muscle.
BioSig Technologies, Inc. ("BioSig") has developed an electrophysiology signal processing system, the PURE EP System, which may allow electrophysiologists to better characterize arrhythmogenic tissue during ablation procedures. cardiolab electrophysiology recording system. The CardioLab Electrophysiology recording system is designed to help you optimize your workflow, productivity and throughput.
View this study on Beta.ClinicalTrials.gov. CardioLab EP Recording System Essential functionality. Continued Excellence for Your Evolving EP Lab Needs.
CardioLab EP Recording System - GE Healthcare 2023 GE HealthCare. Therefore, improvement of the fidelity of signals obtained from EP recording systems is needed to enhance identification of the most effective targets for ablation. MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS. Mac-Lab offers innovative capabilities and functionality to deliver a system that is easy to use and customized to your workflow, while maintaining a strong focus on comprehensive IT data integration, interoperability between systems and solutions and the evolving requirements of cybersecurity. As such, we performed unipolar and bipolar cardiac conduction system mapping using various catheters while simultaneously comparing PURE-EP (0.05 to 1 kHz, 24-bit A/D conversion, 2000 samples/s sampling rate, low gain with no saturation in the 250 mV range) with a standard recording system (0.05 to 500 Hz, 12-bit A/D conversion, 977 samples . Find out who we are, explore careers at the company, and view our financial performance. The intracardiac signals from the PURE EP system will be compared to existing recording and mapping system signals generated in real-time during each ablation procedure. The existing systems will serve as the primary method of viewing intracardiac signals and the PURE EP system will be redundant. A Cascade PRO 16-channel electrophysiological diagnostic system produced by Cadwell, USA, was used to record the evoked EMG. Study record managers: refer to the Data Element Definitions if submitting registration or results information. From admittance and diagnosis to treatment and billing, CardioLab helps optimize workflow, productivity, and throughput. excellent signal quality with advanced EP applications is designed to enhance EP procedures. When you need it.
ELECTROPHYSIOLOGY RECORDING SYSTEM CARDIOLAB IT - StoresAndMarket During the ablation procedures, annotations will be captured on the PURE EP system based on pre-determined clinically relevant events defined in this protocol (example - before and after successful ablation therapy). This study is designed to collect parallel intracardiac signal data during pre-defined periods of clinical interest from the PURE EP system and the existing signal recording and mapping systems. CardioLab Recording Systems - EP Recording - Categories. CardioLab Recording Systems - EP Recording - Categories. CardioLab Electrophysiology Recording Systems Where you need it. CardioLab offers innovative capabilities and functionality to deliver a system that is easy to use and customized to your workflow, while maintaining a strong focus on comprehensive IT data integration, interoperability . Individual Participant Data (IPD) Sharing Statement: Collected intracardiac signal samples will be shared with the independent electrophysiologist reviewers, other physician investigators, and possibly other study collaborators like a biostatistician and clinical research organization. Exceptional performance. CardioLab Recording Systems - EP Recording - Categories. The CardioLab Electrophysiology recording system is designed to help you optimize your workflow, productivity and throughput. GE Is A Trademark Of General Electric Company.
Read our, ClinicalTrials.gov Identifier: NCT04112433, Novel Cardiac Signal Processing System for Electrophysiology Procedures, 18 Years and older (Adult, Older Adult), Jacksonville, Florida, United States, 32224, Boston, Massachusetts, United States, 02114. Please remove one or more studies before adding more. Choosing to participate in a study is an important personal decision. 510 (k) Number. Intuitive controls at your fingertips. Enrolled patients receiving cardiac ablation treatment using the current standard of care with additional monitoring and intracardiac electrogram signal collection via the PURE EP 2 system. The CardioLab Electrophysiology recording system is designed to help you optimize your workflow, productivity and throughput.
CardioLab | Duomed Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Safe and effective use of the PURE EP 2 system based on system specifications and recorded within the Case Report Form (CRF). GE Is A Trademark Of General Electric Company. CardioLab helps make your life easier and your workflow smoother. Current recording systems have limitations in that it can be difficult to clearly distinguish a true cardiac signal from noise or artifact. When used with the. This powerful central server and a series of point-of-care workstations is designed to help reduce delay and redundant data entry. .ge-cdx-header-redesign__authentication-menu-container__register-btn :active {color: #222222;border: 1px solid #222222;}. Essential functionality. The secondary aim of this study is to assess the quality of the PURE EP intracardiac signals and the associated clinical relevance of the signals when compared to other sources of intracardiac signals. Provides significant improvements to workflow management by allowing you to use the clinical LABSYSTEM PRO EP Recording System as a workstation for case review, study annotation and report generation.
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