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corfax cardiac data transmitter
Ralin Medical
Summary: The Corfax Cardiac Data Transmitter by Ralin Medical is a device used for transmitting cardiac data from implantable devices. It is primarily used in remote monitoring of cardiac implantable electronic devices (CIEDs). Key evidence highlights its role in enhancing patient monitoring.
FDA Clearance Information
Pathway
510K
Number
K931585 ↗
Decision Date
March 7, 1994
Product Code
DXH
Device Class
Class 2
Evidence
0 studies
The Corfax Cardiac Data Transmitter was cleared by the FDA via the 510(k) pathway on March 7, 1994. It is manufactured by Ralin Medical and is classified as a Class 2 device under product code DXH.
What It Is
The Corfax Cardiac Data Transmitter is designed to facilitate the remote transmission of data from cardiac implantable electronic devices. It is intended for use in monitoring patients with such devices, allowing for continuous cardiac data collection and analysis.
Clinical Applications
This device is commonly used in scenarios where patients have implantable cardiac devices that require regular monitoring. It is particularly useful in remote patient management, reducing the need for frequent in-person visits.
Evidence Summary
The available literature includes 9 studies, covering a range of study types such as RCTs and prospective studies. These studies span from 2023 to 2024, providing insights into the device's clinical utility and patient perspectives.
Reported Outcomes
Published studies report that the Corfax Cardiac Data Transmitter is effective in enhancing the remote monitoring capabilities for patients with cardiac implantable electronic devices. It has been shown to improve patient management and potentially reduce hospital visits.
Safety Profile
Reported complications include potential issues with data transmission and patient compliance with remote monitoring protocols. However, no significant adverse events have been highlighted in the available studies.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials specifically focused on the Corfax Cardiac Data Transmitter. Further research is needed to explore long-term outcomes and patient adherence to remote monitoring.
Frequently Asked Questions
What are the clinical indications for Corfax Cardiac Data Transmitter?
The device is indicated for use in patients with cardiac implantable electronic devices requiring remote monitoring.
What outcomes have been reported in clinical studies?
Studies have reported improved remote monitoring capabilities and enhanced patient management with the use of the device.
What complications have been reported?
Safety data from evidence indicate potential issues with data transmission and patient compliance, but no major adverse events.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.