Sirona Medical Secures FDA Clearance for Cloud-Native PET-CT Imaging Suite

Sirona Medical has announced that its Sirona Advanced Imaging Suite has received 510(k) clearance from the U.S. Food and Drug Administration, marking a pivotal regulatory achievement and the company’s first Class II medical device designation. The clearance brings expanded diagnostic imaging capabilities to Sirona’s platform, including support for PET-CT imaging with quantitative SUV analysis, image fusion, maximum intensity projection (MIP), and multi-planar reconstruction (MPR).

This latest development is a key step in Sirona’s broader mission to unify radiology workflows through a cloud-native platform that enables advanced visualization, collaboration, and reporting—all accessible directly through a web browser.

“This milestone reflects our commitment to closing the most critical capability gaps that limit the flexibility and reach of modern radiology,” said Dr. Peter Sachs, Radiologist, Imaging Informaticist, and advisor to Sirona. “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 FDA clearance follows years of development involving cross-functional teams across Sirona’s product, engineering, and regulatory departments. The result is a system that removes traditional barriers to software deployment in radiology, where advanced tools typically require localized installation and ongoing maintenance. With Sirona’s architecture, new features like PET-CT imaging can be pushed instantly across the platform to all users—streamlining the rollout process and eliminating the need for site-specific configurations.

“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,” said Ken Kaufman, Chief Executive Officer of Sirona Medical. “This is a foundational milestone for our customers.”

The newly cleared imaging suite will begin rolling out to customers starting next week, with immediate availability for users already enrolled in early-access programs. The company’s approach to cloud-native design allows it to update features and capabilities continuously, aligning product innovation with clinical demand in real time.

Sirona is also using the momentum of this regulatory win to engage the broader radiology community. On November 5, 2025, it will host a webinar titled “The Cloud-Native Path to Profitable Radiology,” featuring Dr. Luke Roller and Dr. Jon Masur. The session will focus on how cloud-based platforms like Sirona’s RadOS™ are reshaping the economics and efficiency of radiology by eliminating workflow silos and integrating PACS, reporting, and AI within a single interface.

In addition, Sirona will be demonstrating its solutions live at the upcoming Radiological Society of North America (RSNA) Annual Meeting. Visitors to Booth 4569 will have an opportunity to explore RadOS™ firsthand and see how Sirona is redefining diagnostic imaging for a cloud-enabled future.

With this FDA clearance, Sirona Medical positions itself at the forefront of digital radiology, offering a scalable and streamlined platform that could help reshape how imaging services are delivered across healthcare systems.