Sectra and Leica Biosystems first in the world to gain FDA clearance to utilize DICOM images for pathology diagnostics
Linköping, Sweden – April 29, 2024 – International medical imaging IT and Cybersecurity company Sectra’s (STO: SECT B) digital pathology solution together with Leica Biosystems, Imaging, Inc.’s Aperio GT 450 DX have received a 510(k) clearance by the US Food & Drug Administration (FDA). This is the first time an FDA clearance within digital pathology allows the use of DICOM images for pathology diagnostics, which marks a significant step towards standardization in this field.Sectra received its first FDA clearance during the pandemic, in 2020. The pandemic made the