FDAEcg Suite

 

FDAEcg Suite Details

Displaying, validating, reviewing and scoring ECG files

The FDAEcg Suite is an advanced Viewer for resting ECGs in FDA HL7 XML format.
This AMPS software provides a way to display, review, score and validate ECG files in the format supported by the US FDA (aECG FDA HL7 XML, v. 1). ECG files in ISHNE format are also supported.

In addition to a complete customizable ECG display for Rhythm strip (raw data) and Representative Beats (medians) waveforms, the software includes the validation and scoring modules.
The former module verifies that both the structure and content of the HL7 XML files meet the requirements embodied in the HL7 Schema and the HL7 Implementation Guide endorsed by the FDA (see HL7 aECG Implementation Guide and Beyond the Schema documents available on the Technical documents page on our website).

Thanks to the strategic alliance signed with Mortara Instruments Inc. in August 2006, the FDAEcg Suite and the FDAEcgWarehouse produce a consistent set of syntactical warnings and error messages during the validation phase, thus giving a consistent interpretation of the HL7 XML standard requirements.
The scoring module measures the quality of the loaded ECGs, via several predefined metrics, such as:

  • Heart rate
  • QRS complexes heterogeneity
  • Protocol agreement percentage
  • Following annotation based metrics: QT, QTcB, QTcF
  • Lead specific (I, II, III, aVR, aVL, aVF, V1…V6) and all leads LF noise
  • Lead specific and all leads HF noise & All frequencies noise
  • Lead specific HF noise around T-wave offset
  • Lead specific T-wave amplitude

History: As of January 20th, 2004 the Annotated ECG (aECG) XML Waveform Standard was finalized and 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. Badilini was part of the panel and received an Award from the FDA for his contribution.

The FDAEcg Suite is fully modular, the Viewer, Validation and Score modules can be combined independently: all combination of the three modules are possible (view FDAEcg Suite Plugins).

FDAEcg Suite plugins


Viewer Light FDAEcg Suite Notes
Against Schema Validation Yes Yes This validation checks if all used elements conform to the XML syntax rules and to the HL7 Schema
IG Level Validation No Yes 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.
FDA Warehouse Validation No Yes 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).
Folder-based validation No Yes Validation can be computed on a single file or on an entire folder in a single step.
Folder-based file management No Yes The user can open the whole content browsing from an ECG to another without the need of additional open sessions.
The application gives the user the possibility to browse between ECGs and enrolled subjects of the same study, with identical trial code.
Enhanced display options Yes Yes Advanced and totally customizable ECG display. Possibility of changing lead organization, grid appearance and dimensions, zoom…
Toggle on/off annotations Yes Yes It is possible to turn on and off the display of annotations by type.
ECG Scoring No Yes 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.

FDAECG Suite Demo

FDAEcg SUITE   (demo version)

Version:

2.0

Date:

August, 2012

Size:

18.7 MB

Download:

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The FDAEcg Suite is an advanced Viewer for resting ECGs in FDA HL7 XML format. This AMPS software provides a way to display, review, score and validate ECG files in the format supported by the US FDA (aECG FDA HL7 XML, v. 1). ECG files in ISHNE format are also supported.
in August 2006, the FDAEcg Suite and the FDA ECG Warehouse produce a consistent set of syntactical warnings and error messages during the validation phase thus giving a consistent interpretation of the HL7 XML standard requirements. The scoring module measures the quality of the loaded ECGs.

A User Manual is included in the setup package, automatically copied in the installation folder.

Demo versions of all AMPS software are fully functional only with the example demo data files included in the setup package.

FDAEcg Suite Learn More

Clicking here below you can view a set of slides illustrating FDAEcg Suite software.

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