Sirona Medical has received FDA 510(k) clearance for its Sirona Advanced Imaging Suite, marking the company's first Class II medical device designation. This approval enhances its diagnostic imaging capabilities, particularly with PET-CT support that includes quantitative analysis, image fusion, and advanced reconstruction methods. CEO Ken Kaufman stated this marks a significant achievement in providing a cloud-native diagnostic environment. The suite will be available for rollout next week to existing customers and will be demonstrated at the upcoming Radiological Society of North America Annual Meeting.
Thu, 30 Oct 2025 12:00:00 GMT | PR Newswire