The US Food and Drug Administration (FDA) has granted 510(k) clearance to Sirona Medical’s Advanced Imaging Suite.
This move marks the company’s inaugural receipt of Class II medical device status.
The latest clearance broadens the company’s diagnostic imaging scope to include positron emission tomography-computed tomography (PET-CT) support with quantitative standardised uptake value (SUV) analysis, generation of maximum intensity projection (MIP), image fusion, and multi-planar reconstruction (MPR).
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The achievement of the designation comes after coordinated work involving the company’s engineering, product, quality and regulatory divisions.
According to Sirona, the new functionality is designed to enhance radiology workflow by integrating visualisation, reporting and partnership tools within a cloud-native environment.
Sirona highlights that the new clearance allows for deployment of updates and new functionalities to all users, eliminating the need for individual site installations or prolonged upgrade processes.
The company plans to start the rollout of the imaging suite to users starting next week. Current customers involved in early-access initiatives will receive immediate access to the new functionality.
Sirona Medical CEO Ken Kaufman said: “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.”
Sirona Medical is focused on integrating radiology IT applications and AI into a single cloud-native workspace built on its RadOS operating system.
In November 2024, the company raised $45m in Series C funding, which included equity and converted debt. This round was spearheaded by Avidity Partners.
The investment was directed towards advancing its Unify platform, particularly to improve workflow efficiency and AI-enabled reporting, as well as support ongoing customer service initiatives.
