News

Sirona Medical has announced that it has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, a major regulatory achievement and the company’s first Class II medical device designation.

This FDA clearance broadens Sirona’s diagnostic imaging portfolio to include PET-CT functionality, offering quantitative SUV analysis, image fusion, maximum intensity projection (MIP) creation, and multi-planar reconstruction (MPR).

“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 Sirona Advisor. “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 clearance is the result of a comprehensive, cross-functional collaboration across Sirona’s product, engineering, quality, and regulatory teams. The newly approved features mark an important advancement in Sirona’s goal to streamline the radiology workflow by integrating advanced visualization, reporting, and collaboration tools within a unified, browser-based cloud platform.

“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.”

Sirona’s fully cloud-native architecture transforms the way innovation is delivered to radiologists. With FDA clearance of the Sirona Advanced Imaging Suite, deploying new functionality no longer requires complicated on-site installations or time-consuming upgrade cycles. Instead, updates can be instantly rolled out to every user via the cloud.

The Sirona Advanced Imaging Suite will begin deployment to users as soon as next week, with immediate access available to existing customers enrolled in early-access programs.

© Sirona Medical