CAMBRIDGE, Mass., Nov. 20, 2014 /PRNewswire/ -- AZE Technology today announces the U.S. Food and Drug Administration (FDA) approval of Phoenix (Volume Registration Viewer), a viewer developed with a completely new concept for efficient and accurate image interpretation. Phoenix is designed with background volume-processing performed at the same time as data input, and presents various dramatic outcomes that were not possible with existing viewers.
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Clinical Trial Results Supporting FDA Approval
Phoenix was validated against the previously-cleared predicate device VirtualPlace (K060453) (VP) from AZE, Ltd. Two (2) sample images were used for this validation; one thoracic CT image and one thoracic MR image. Three human observers made three independent observations of thirteen (13) measurements with corresponding measurement tools in the two software programs (Phoenix and VirtualPlace) from the CT and MR images. This created 3 observers * 3 observations * 13 measurements * 2 software programs * 2 images = 468 values.
Conclusions:
The only significant differences between Phoenix and the market-cleared VirtualPlace software measurement tools across thirteen measurements made by three observers on images from two modalities (CT and MRI) were RECIST measures. The increased lengths measured by the Phoenix RECIST tools were explained by Phoenix RECIST finding the longest distances and tightest edges as described earlier. Additionally, measurements with Phoenix tools on a phantom of a known diameter came up within 2% of the known values. Phoenix’s measurement values can be considered valid because they differ significantly from the previously market-cleared VirtualPlace or from known values of a phantom.
Indications Usage
Phoenix is designed for viewing CT/MRI images on a more advanced level. With Tumor-size comparison by using fusion and superimposition, it allows the Radiologists to provide a greater amount of information quickly. Used in tumor evaluation for not only cancer patients, but for any type of mass being evaluated.
The RECIST measurement feature conforms fully with established international guidelines, in order to make judgments about treatment effect of solid tumors. It obtains data from all aspects of the tumor, giving a higher level of information to the referring physicians, and in return establishing accurate patient treatment.
Instant matching of section positions helps reduce the time involved in reading exams, and in return increases the turnaround of clinical reports.
Phoenix is enhanced with multiple advanced tools, hanging protocols and Smart Tags. AZE VirtualPlace 3D workstation can also be interface with Phoenix, combining the best of both worlds.
About AZE Technology
AZE Technology develops powerful, FDA-approved visualization and analysis tools for the healthcare industry, delivering unsurpassed 3D image processing, analysis and data management. AZE scientists and engineers design solutions for prominent research facilities in the United States and overseas, relying on extensive experience in diagnostic radiology image tool design and architecture. AZE Technology gives clinicians a cost-effective path to rapid, accurate diagnosis and sophisticated treatment planning systems, through innovative technology and expert consultancy.
For more information, please visithttp://www.azetech.com
SOURCE AZE Technology, Inc.
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