Sirona Medical Receives FDA Clearance for Advanced Imaging Suite

The Food and Drug Administration (FDA) has issued 510(k) clearance for the Sirona Advanced Imaging Suite, which reportedly combines enhanced positron emission tomography/computed tomography (PET/CT) capabilities with the accessibility of a cloud-native platform.

The Sirona Advanced Imaging Suite provides a variety of attributes including image fusion, multiplanar reconstruction, maximum intensity projection and quantitative standardized uptake value (SUV) analysis for PET/CT imaging, according to Sirona Medical, the developer of the Sirona Advanced Imaging Suite.

In addition to the expanded utility with PET/CT interpretation, Sirona Medical said the Sirona Advanced Imaging Suite facilitates streamlined reporting and collaboration through a cloud-native platform.

"This milestone reflects our commitment to closing the most critical capability gaps that limit the flexibility and reach of modern radiology," noted Peter Sachs, M.D., a radiologist and advisor with Sirona Medical. "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."