Agfa HealthCare Receives FDA 510(k) Clearance for XERO®

Agfa HealthCare receives FDA 510(k) clearance for XERO®
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XERO “footprint” Viewer now provides easy unified access to patient images from different departments in either reference or diagnostic quality

Mortsel, Belgium –

  • “Full Fidelity View” enables retrieval of original renditions of stored CR, DX, CT, MR, CR and US images, for diagnostic purposes.
  • More than 500 XERO Viewer solutions installed around the world.
  • XERO features includes clinical and specialty measurement tools, as well as tools for enhanced collaboration.

Agfa HealthCare announces today that it has received FDA 510(k) clearance for diagnostic viewing with the XERO Viewer. This Full Fidelity View functionality of the viewer uses loss less compression to provide diagnostic quality when images are displayed, by retrieving original-quality renditions of stored DX, CT, MRI, CR and US images.

Worldwide deployment

Already, over 500 XERO Viewer solutions have been installed around the world, at both large regional networks to enable comprehensive image and information sharing as well as in individual hospitals needing both internal and external imaging and information distribution.  Installations include more than 50 seamless integrations with healthcare enterprises’ electronic health records (EHRs) to image enable the EMR.

“As we produce more and more reports and images, it is absolutely critical that we have effective and efficient solutions to make them accessible, in digital format,” says Dott. Robert Tarducci, Health Physics director of Azienda Ospedaliera di Perugia, Italy. “By allowing the regional centers to quickly and effectively access the information they need, it will support the enhanced diagnostic confidence and will save time for caregivers.”

Enhanced staff and patient satisfaction

With Agfa HealthCare’s XERO Viewer, users will benefit from enhanced viewing, sharing and integration across platforms, with all images accessible on a single browser-based viewer.  The XERO Viewer provides secure access to DICOM and non-DICOM imaging data from different departments and multiple sources, in one view, to anyone inside and outside of the hospital who needs it.

The XERO Viewer interface is easy to navigate and offers extensive search, filter and discovery functions. Clinicians and radiologists alike can easily make annotations and markups, adapt brightness and contrast, or pinpoint an area of interest and compare it across different studies. In addition, users can view ECGs in various layouts, change waveform size and amplitude, and compare image data with previous ECGs.  Other subspeciality tools include Cine display, universal video viewing, optional 3D/MIP/MPR tools and specialty measurement tools.  The patient-centric, interactive timeline offers a big leap forward in understanding the patient’s story with a thumbnail enabled, study-by-study, unified view of all the patient’s images.

“No barriers” imaging

 Mobile device support meets the increased demand for mobility, allowing caregivers to view, capture and upload images, even at locations with low bandwidth.

Chat and share tools let colleagues look at the same image, making mark-ups and measurements that both can see, all while communicating directly online.

The XERO viewer supports a care-centric healthcare model, by facilitating real-time collaboration between all players in the patient’s care.

Part of a consolidated imaging platform solution

The XERO Viewer can be a key part of a workflow-centric Enterprise Imaging solution that offers physicians a single platform and a single vision: every image, everywhere at every moment.  Seamlessly creating a comprehensive medical record, while providing all tools to collaborate, exchange, view and manage imaging data, Enterprise Imaging offers a true eco-system that will bring clinical value along the care continuum while increasing productivity and enhancing the value of care.  A consolidated IT infrastructure optimizes the use of your investments resulting in lower IT costs and an enhanced workflow of caregivers.

Maximizing potential of existing healthcare technology

“The XERO Viewer demystifies imaging and makes it accessible to everyone in the patient’s care continuum,” comments James Jay, Vice President Imaging IT solution of Agfa HealthCare. “Hospitals today face the challenge of simultaneously reducing the costs of healthcare and improving the delivery of patient care. The XERO Viewer helps to maximize the potential of the existing healthcare technology while giving clinicians, referring physicians and patients the image access they want and need. The FDA 510(k) clearance for the XERO Viewer’s diagnostic viewing functionality takes this another step forward.”
Source credit: Agfa HealthCare

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