Ziosoft Receives FDA 510(k) Clearance for Dual CT kV Analysis

BELMONT, Calif., June 16, 2020 /PRNewswire-PRWeb/ -- Ziosoft, a pioneer in 3D/4D medical AI visualization, announced it has received a 510(k) clearance from the Food and Drug Administration (FDA) for Computed Tomography (CT) Dual Energy Analysis software on the company's flagship Ziostation2 system. Studies show that dual energy CT provides several advantages over single energy CT for both diagnosis and therapy response evaluation.

"CT is the workhorse of modern medical imaging," said Rajeev Taitriya, vice president of Business Development and Marketing for Ziosoft. "This important modality accounts for approximately more than 80 million exams per year in the United States alone. With the addition of our new software to images produced from any manufacturer's CT system, increased diagnostic confidence could help in multiple applications, such as cardiac and lesion analysis."

Technical advances, like faster scan times, thinner slices, multi-planar reformatting and 3D rendering, have revolutionized the scope of CT.

Dual energy CT (DECT) offers numerous applications and possibilities previously unavailable with conventional single energy CT. DECT involves the use of different kV (Kilovoltage) levels during the CT exam. This enables dual energy CT systems to exploit the different Hounsfield unit (HU) values for materials through different energies to decompose images into the components making up these materials.

The potential benefits of DECT include increased lesion detection and characterization, improved oncological staging and evaluation of treatment response, artifact reduction and many other applications, all at comparable or even reduced radiation doses (kV). For example, in liver analysis, DECT can provide improved screening, reduced follow up studies and possibly decrease the need for biopsy. It could also offer increased potential for treatment response evaluation.

With the Ziostation2 software system, it is possible to create masks to remove bone and other visual obstructions from the CT studies. This also enables the ability to measure HU attenuation factors to determine material decomposition. Additionally, images can also be created from the multi-kVp datasets, including virtual non-contrast, energy subtraction and image blending.

The Ziosoft application software is an image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources. This application software also receives medical image data from other modalities (MRI, Ultrasound, Digital X-ray, X-ray, Angiography, PET, SPECT and others) directly from these modalities or image archives such as PACS through network or media. It then provides for the viewing, quantification, manipulation, communication, printing and management of medical images.

Key features include graphical histograms for viewing the desired energy level and extracting objects, specifying ROIs directly on the graph and saving mask information. It also easily creates virtual non-contrast and multi-kV blended images, in addition, it can produce separate energy structures for masking or bone removal.

"The Ziosoft protocol CT Dual kV analysis generates blended, subtraction, virtual non-contrast and iodine map images," said Taitriya. "It then saves the results in a new image series for analysis. We believe this provides a powerful tool for clinicians in a number of applications when seeking accurate diagnosis and therapeutic evaluation."

About Ziosoft, Inc.

Ziosoft provides a comprehensive multi-modality, advanced processing and viewing solution for any specialty. Its customizable platform provides automated workflow to maximize efficiency. It is also a scalable, enterprise platform for "anywhere" accessibility and, as a software-only platform, it is simplified to minimize cost of ownership. For further information, visit http://www.ziosoftinc.com.

SOURCE Ziosoft, Inc