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Displaying and validating XML FDA Ecg files
You can use the Viewer Light for resting ECGs in the FDA HL7 XML format. This AMPS software tool provides a method to display and validate this type of formatted ECG files.
As with other AMPS tools, the Viewer Light is based on the FDAEcg Suite architecture, however it offers a reduced set (Light) of functionalities. Both applications are capable of rendering/displaying HL7 annotated ECG files. Of course, Viewer Light supports the display of Rhythm strip (raw data) and Representative Beats (medians) waveforms.
The Viewer Light processes a single ECG at a time and has a reduced set of functionalities , while the FDAEcg Suite has an extensive set of qualitative and quantitative tools ranging from ECG quality scoring to different HL7 XML validation levels.
Viewer Light Plugins:
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Viewer Light |
FDAEcg Suite |
Notes |
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Against Schema Validation |
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This validation checks if all used elements conform to the XML syntax rules and to the HL7 Schema. |
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IG Level Validation |
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This validation checks if all used elements conform to the XML syntax rules and to the HL7 Schema. The IG (and this validator) presents information about the aECG standard independently of any particular use. |
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FDA Warehouse Validation |
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This level is specifically aimed to address all issues related with the submission of the aECG files into the FDA warehouse, but that are NOT specified at the level of the schema (or even at the level of the IG). |
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Folder-based validation |
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Validation can be computed on a single file or on an entire folder in a single step. |
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Folder-based file management |
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The user can open the whole content browsing from an ECG to another without the need of additional open sessions. |
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The application gives the user the possibility to browse between ECGs and enrolled subjects of the same study, with identical trial code. |
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Enhanced display options |
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Advanced and totally customizable ECG display. Possibility of changing lead organization, grid appearance and dimensions, zoom… |
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Toggle on/off annotations |
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It is possible to turn on and off the display of annotations by type. |
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ECG Scoring |
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ECGs can be scored using pre-defined or imported plug-ins. Once scored the ECGs can be visualized and sorted based on the different scores, and reviewed. The Suite comes with an open user interface whereby it will be possible to add (plug-in) criteria for new metrics. |
History: Since January 20th, 2004, the Annotated ECG (aECG) XML Waveform Standard became formally adopted by the Health Level 7 (HL7) standards organization. HL7's adoption of the aECG XML Waveform Standard enabled submission of digital aECGs to establish the cardiac safety of new drugs. The final aECG Waveform Standard was authored through an ad hoc group consisting of representatives from sponsor organizations, ECG core laboratories, academic institutions and medical device companies. Dr. Fabio Badilini, AMPS founder, was part of the panel and received an Award from the FDA for his contribution.
Viewer Light Plugins
Click here to view a slide presentation of the Viewer Light.
Ask for a Sample
Please fill out this form to request the Demo version of the AMPS Viewer Light.
Please note that all the Demo versions available via the AMPS web site are fully functional only with the example demo data files included in the setup package. You will not be able to use the Demo version with your own files. A User Manual is included in the setup package, automatically copied in the installation folder.
In order to prevent abuse of this facility we require a valid e-mail address to be provided in order to allow the download of the demo version.
The password needed to open the demo installation package will be sent to the e-mail address you provide in the form.
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An e-mail will be sent to you including a private link to download the demo you requested. If you have any specific question about this product please add them in the "Note" field.