Sectra 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 need and value of remote work even in the field of pathology obvious and has helped boost the adoption of digital pathology in the US. Today, the value of accessing, sharing and reviewing digital images is clear and the market for digital pathology in the US, as well as other countries, is growing rapidly. The FDA clearance includes: Sectra's digital pathology solution when used with Leica Biosystems Aperio GT 450 DX.

SVS and DICOM file formats. Sectra UniView and IDS7 cloud-based and on-premises installation. A digital pathology solution provides instant and, if necessary, remote access to digital images of tissue samples instead of relying on physical glass slides reviewed in microscopes.

This optimizes the workflows for pathologists, leading to enhanced efficiency in cancer diagnostics. The pathology solution is part of Sectra's enterprise imaging solution, which provides a unified strategy for all imaging needs while lowering operational costs. The scalable and modular solution, with a VNA at its core, allows healthcare providers to grow from ology to ology and from enterprise to enterprise.