Sirona Medical Achieves FDA Clearance for Revolutionary Imaging Suite Boosting Diagnostic Capabilities

Sirona Medical Achieves FDA Clearance for Advanced Imaging Suite

Introduction
In a significant advancement for medical imaging, Sirona Medical announces the attainment of FDA 510(k) clearance for its innovative Sirona Advanced Imaging Suite. This pioneering suite not only marks the company’s first designation as a Class II medical device but also promises to revolutionize the capabilities offered to radiologists in the realm of diagnostic imaging.

Enhanced Diagnostic Capabilities
The FDA clearance pertains to a range of new functionality that enhances the diagnostic prowess of the suite. With the integration of PET-CT capabilities, the suite allows for quantitative SUV analysis, image fusion, maximum intensity projection (MIP) generation, and multi-planar reconstruction (MPR). According to Dr. Peter Sachs, a Radiologist and Imaging Informaticist associated with Sirona, this development is essential for addressing critical gaps in radiology, thereby providing greater flexibility and reach in diagnosis.

A Cloud-Native Approach to Radiology
Sirona’s Advanced Imaging Suite is distinctly characterized by its 100% cloud-native architecture, which transforms traditional radiology practices. This means that radiologists can perform complex imaging analysis from virtually anywhere, fostering an environment where diagnostic confidence, speed, and quality are maintained without compromise. The cloud-native approach not only accelerates the installation process for new functionalities but also provides updates instantaneously to users without the extensive downtime typical in traditional systems.

Industry Milestone
CEO Ken Kaufman expressed his enthusiasm regarding the clearance, stating that it signifies a pivotal milestone after a four-year journey to develop the most robust, cloud-native diagnostic environment in the market. By unifying various elements of the radiology workflow into a single platform accessible through web browsers, Sirona aims to streamline radiology practices significantly.

User Rollout and Educational Initiatives
The Advanced Imaging Suite is set to be rolled out to users as soon as next week, prioritizing existing customers engaged in early-access programs. To further support its users, Sirona will host an exclusive webinar titled "The Cloud-Native Path to Profitable Radiology" on November 5, 2025, featuring discussions on how cloud technology is revolutionizing radiology operations. This session aims to educate users about how the RadOS™ platform can alleviate workflow challenges and boost profitability through a unified solution.

Participation in Industry Events
In addition to online educational initiatives, Sirona Medical will be present at the upcoming Radiological Society of North America (RSNA) Annual Meeting, where they'll be showcasing hands-on demonstrations of RadOS™. This event promises to engage industry professionals and highlight the functional improvements brought forth by the Advanced Imaging Suite.

Conclusion
As the healthcare landscape evolves rapidly, innovations like Sirona’s Advanced Imaging Suite set the standard for the future of diagnostic imaging. By empowering radiologists with advanced, accessible technology and support, Sirona Medical is taking crucial steps toward enhancing clinical care and improving patient outcomes. The journey of integrating advanced technology into radiological practices is just beginning, and Sirona Medical is at the forefront of this change.

For more information about Sirona Medical and its offerings, visit www.sironamedical.com.