FDA clears new cloud-native advanced imaging suite

The U.S. Food and Drug Administration has just cleared a new imaging suite developed to provide support for PET/CT workflows. 

Sirona Medical—a company that specializes in cloud-native radiology solutions—announced the regulatory clearance of its Sirona Advanced Imaging Suite on Thursday. The product, which has been expanded to include PET/CT imaging, offers advanced interpretation capabilities to providers.  

The advanced suite gives readers support with multiple technical aspects of PET interpretations, including quantitative analysis, image fusion, maximum intensity projection (MIP) generation and multi-planar reconstruction (MPR). The cloud-native platform also enables remote interpretation and collaboration with other providers. 

"This milestone reflects our commitment to closing the most critical capability gaps that limit the flexibility and reach of modern radiology," Peter Sachs, MD, radiologist, imaging informaticist and Sirona advisor, said in a news release on the clearance. "By pioneering the field of 100% cloud-native PET viewing and PET-CT fusion, we're enabling radiologists to interpret advanced imaging studies from anywhere—without compromise in diagnostic confidence, speed or quality." 

The cloud-based architecture also provides seamless updates when needed. It does not require site-by-site installations or time-consuming update cycles, and its numerous functions are available through a single browser.  

"With PET-CT now cleared, Sirona has completed a four-year journey toward delivering the most complete, FDA-cleared, and cloud native diagnostic environment in the industry," CEO Ken Kaufman added. "This is a foundational milestone for our customers." 

The clearance marks the company’s first Class 2 medical device designation. It will become available to new users as early as next week.  

Learn more about the company’s offerings here.