Sirona Medical has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Sirona Advanced Imaging Suite. This is a major regulatory achievement for the company and marks its first Class II medical device designation. The clearance enables Sirona to add PET-CT capabilities to its diagnostic imaging services, along with features like quantitative SUV analysis, image fusion, maximum intensity projection creation, and multi-planar reconstruction.
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Dr. Peter Sachs, a radiologist, imaging informaticist, and Sirona advisor, highlighted the importance of this milestone. He noted that it reflects the company’s commitment to solving long-standing issues that have limited flexibility and accessibility in modern radiology. He also explained that by creating fully cloud-native PET viewing and PET-CT fusion tools, Sirona allows radiologists to analyze advanced imaging studies from anywhere without lowering speed, diagnostic accuracy, or image quality.
This clearance came from extensive teamwork across Sirona’s product, engineering, quality, and regulatory departments. The newly approved features are a key part of the company’s mission to streamline radiology workflows by integrating advanced visualization, reporting, and collaboration into one cloud-native platform that can be used through a standard web browser.
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Ken Kaufman, CEO of Sirona Medical, mentioned that adding PET-CT capabilities completes a four-year effort to provide the most comprehensive FDA-cleared cloud-native diagnostic imaging environment in the industry. He described the clearance as a crucial milestone that strengthens Sirona’s offerings for its customers and improves the overall radiology experience.
Sirona’s cloud-native approach means new imaging features can be delivered to radiologists quickly without the need for complex on-site setups or long upgrade processes. With the FDA clearance, the Sirona Advanced Imaging Suite will start being rolled out to users as early as next week, with immediate access for existing customers who are part of early-access programs.
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