Sirona Medical Gains FDA Clearance for Advanced Imaging Suite, Expanding PET/CT Diagnostic Capabilities
Sirona Medical, a San Francisco-based healthcare technology company, has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite. The clearance marks the company’s first Class II medical device designation and significantly broadens its diagnostic imaging capabilities, including advanced PET/CT functionality.
The newly cleared system supports quantitative SUV analysis, image fusion, maximum intensity projection (MIP) generation, and multi-planar reconstruction (MPR). These features enable radiologists to interpret PET and PET/CT studies remotely with high precision, extending the flexibility of modern imaging workflows. “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 FDA clearance follows years of coordinated work across Sirona’s engineering, product, and regulatory teams. It represents a key step in the company’s goal of unifying radiology workflows through a fully cloud-native environment that integrates visualization, reporting, and collaboration tools. Chief Executive Officer Ken Kaufman noted, “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. This is a foundational milestone for our customers.”
Built on a cloud-based architecture, the Sirona Advanced Imaging Suite eliminates the need for on-site installations or manual upgrades. New capabilities can be deployed instantly through the cloud, enabling continuous improvement without disrupting hospital IT systems. The suite will begin rolling out to users next week, with early access for existing customers.
Sirona will demonstrate the new platform at the Radiological Society of North America (RSNA) Annual Meeting, where attendees can explore its RadOS™ operating system and learn how unified, cloud-native workflows are reshaping diagnostic imaging. The company will also host a November 5 webinar featuring discussions on how cloud technology can enhance efficiency and profitability in radiology practices.
