What is FXA?

Functional X-ray Analysis – Motion Analysis and Quantification of Functional X-rays

Today the analysis of medical images (X-ray, CT, MRI) is typically concentrating on static characteristics. For example, in order to investigate a disease of the spine, the disk height, the translational shift of vertebrae or the narrowing of the spinal canal is determined based on medical images.
Due to the lack of feasible tools, it is hardly possible in the daily routine to evaluate further parameters such as, for example, the location of the center of rotation (CoR) or angular and translational relative motion.
These parameters give however valuable information on the current state of degeneration of a spinal segment.
With the FXA software it is now possible for the first time to utilize these parameters as part of clinical investigations. Moreover, this software is ideally suited to assess the radiographical outcome of orthopedic treatments within clinical studies or post-market surveillance.

Advantages:

1.

Acceleration and improvement of the implant development process by enabling insight into the precise function and interaction of an implant with its surrounding structures – in-vitro and in-vivo.

2.

Support in patient selection within clinical studies through an objective, observer independent screening of various parameters such as disk height, instability or range of motion (RoM).

3.

Supply of scientific data and evidence for regulatory approval procedures of new treatments or implants, and to support training, marketing and user education programs with unbiased class-1 data.

Functionality

Behind the scenes of the FXA-Software

The analysis of the x-ray, computer tomographic (CT) or magnetic resonance images (MRI) is essentially carried out in five steps:

1.

First, the images (for example in DICOM, JPG or TIF format) are imported into the FXA software and a manual selection of the areas of interest is made.
The selection may be, for example, vertebrae, bony structures or implants.

2.

The FXA software then processes the images with state of the art filters and procedures known from digital image processing. Hereby unwanted noise is reduced and the image clarity and definition is improved.

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Our service for You

Analyse eines Röntgenbildes am PC

We provide the analysis of X-ray, CT or MRI images utilizing the FXA software for you as surgeon, medical device manufacturer or CRO. Predominantly this is used for the documentation and clinical monitoring of implant function in regard to safety and efficacy within clinical trials and post-market surveillance.

Besides this, the FXA software was successfully utilized a as tool to optimize implants during preclinical biomechanical testing.

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News

11/018/2011 - FDA Approval

This week the FDA has approved our software for the most precise motion quantification and image analysis of medical images. With this approval we can now offer our imaging core lab services for image analyses to clients seeking approval for their products in the United States through clinical trials (IDE-PMA or other pathways) involving radiographic, clinical data.

04/18/2011 - Validation Study Published

Our validation study to confirm the FXA measurement accuracy was published in the Journal of Biomechanics. The abstract is accessible though this link: A method to perform spinal motion analysis from functional X-ray images

FXA, a development by

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