tim.hodson
Thu, 10/30/2025 – 14:12
Oct. 30, 2025 — Sirona Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, marking a significant regulatory milestone and the company’s first Class II medical device designation.
This clearance expands Sirona’s diagnostic imaging capabilities to include PET-CT support with quantitative SUV analysis, image fusion, maximum intensity projection (MIP) generation and multi-planar reconstr…