Sirona Medical wins FDA Clearance for cloud-based advanced imaging suite

Sirona Medical has received U.S. Food and Drug Administration 510(k) clearance for its Sirona Advanced Imaging Suite, the company’s first Class II medical device designation and a key milestone in its push to modernize radiology through the cloud.

The clearance expands Sirona’s diagnostic imaging capabilities to include PET-CT support with quantitative standardized uptake value analysis, image fusion, maximum intensity projection generation, and multi-planar reconstruction.

“This milestone reflects our commitment to closing the most critical capability gaps that limit the flexibility and reach of modern radiology,” said 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 FDA clearance represents the culmination of a four-year effort across Sirona’s product, engineering, quality, and regulatory teams, according to the company. The newly approved functionality brings Sirona closer to its goal of unifying radiology workflows by combining advanced visualization, reporting, and collaboration within a single browser-based 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, Sirona’s chief executive officer. “This is a foundational milestone for our customers.”

Sirona said the cloud-based design of its platform eliminates the need for traditional on-site installations or time-consuming software upgrades. Instead, new features can be rolled out to all users simultaneously through the cloud.

The Advanced Imaging Suite will begin rolling out to users as early as next week, with immediate access for customers already in early-access programs.

Advances in radiology and imaging technology

Radiology has entered a period of rapid innovation as health care systems seek to improve diagnostic accuracy, reduce costs, and enhance collaboration across care teams. One of the most significant trends has been the migration of imaging software and data management to cloud-based environments. These platforms allow radiologists to access, analyze, and share high-resolution images from any location, reducing reliance on local servers and eliminating delays caused by traditional software updates or data transfers.

Another area of advancement is in artificial intelligence and machine learning, which are increasingly being used to assist radiologists in image interpretation and workflow management. Algorithms trained on large datasets can flag potential abnormalities, prioritize urgent cases, and automate routine measurements — all while maintaining or improving diagnostic precision. These tools are particularly valuable in PET-CT and MRI imaging, where subtle variations in tissue density or tracer uptake can indicate early signs of disease.

Interoperability has also become a focus, as hospitals and imaging centers work to integrate data from multiple systems and imaging modalities into unified platforms. The ability to combine images, reports, and analytics into a single interface enables more efficient collaboration between radiologists, referring physicians, and specialists.

Finally, remote reading and virtual collaboration are expanding access to radiology expertise in underserved regions. By leveraging secure, cloud-enabled systems, radiologists can now provide consultations and interpretations across time zones, accelerating diagnosis and treatment planning while supporting more flexible work environments. Together, these advances are reshaping the field of medical imaging, making it faster, more connected, and more adaptive to the evolving needs of modern health care.