Our service for you

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.

For radiologic assessments and diagnosis beyond the scope of the FXA software functionality, we work together with a team of experienced radiologists and can thereby offer a complete service ranging from an imaging core lab, neural and independent.

How we work

Ideally, we participate during the creation of the study protocol and share our knowledge regarding radiologic parameters and possible measures to achieve a steady, high-level image quality under daily practice conditions.

As the study progresses, the clinics or CROs transmit the images to us, preferably by email or our secure upload site. Typically, the images include Pre-OP, Post-OP and various follow-up time points.

The FXA software and/or our radiologic team consecutively analyze the flexion, neutral and extension images, allowing continuous monitoring of the study's progress.

By the end of the study or post-market surveillance, the data is statistically analyzed and a study report prepared.

News

11/018/2011 - FDA Approval

Today 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