Radical Imaging has secured US Food and Drug Administration (FDA) approval for its software as a service (SaaS) image viewer, FlexView Diagnostic, for diagnostic use.
The clearance allows healthcare professionals to access medical images for diagnostic purposes directly from the cloud, without the need for software installation.
Designed to be user friendly, the FlexView Diagnostic stand-alone web-based DICOM medical image viewer features a clean and intuitive interface that simplifies the diagnostic process for radiologists and clinicians.
It is equipped to handle large imaging studies easily, ensuring that even the most extensive data sets can be loaded quickly.
The system also has advanced imaging features such as 3D rendering, multi-modality fusion and segmentation.
Integration with existing healthcare platforms is seamless, as FlexView Diagnostic can be incorporated into other software systems within a day.
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By GlobalDataRadical Imaging CEO Rob Lewis said: “It is gratifying to see that the OHIF open-source viewer, the result of our ongoing development collaboration with MGH Department of Radiology, is so widely recognised as useful to the medical imaging community.
“Now, with FlexView Diagnostic, we are excited to be able to offer the same excellent user experience to imaging users who require an FDA-cleared class II medical device for their diagnostic work. With our secure, scalable, cloud-native, easy-to-integrate viewer, rigorous quality process and expert technical support, we aim to simplify and perfect the diagnostic image viewing experience.”
The company said that FlexView Diagnostic is not intended for primary mammographic images diagnosis. It is also not approved for diagnostic use on mobile devices.