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Sectra and Leica Biosystems receives first-in-the-world FDA clearance

Sectra’s digital pathology solution together with Leica Biosystems, Imaging, Inc.’s Aperio GT 450 DX have received a 510(k) clearance by the 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, the companies state.

“Given the rigorous review and clearance process leading up to this point, I see the new FDA clearance as strong proof of the quality of our solution. It is also an enabler for pathology departments to benefit from the latest scanner technology as well as the standardization that is happening within digital pathology. We have already seen how our customers utilize digital pathology to improve patient care, especially in complex cases such as cancer, and I am proud to be part of that journey,” says Elin Kindberg, Global Product Manager Pathology at Sectra.

“Sectra has a strong track record of promoting and enabling open integrations and of pushing the development towards standardization within medical imaging IT. The recent FDA clearance including the clearance to utilize DICOM images for pathology diagnostics therefore makes me very proud. Due to the unique nature of the images used in digital pathology, proprietary formats have previously dominated. This FDA approval, including DICOM, shows that standardization is possible also within pathology. This is an important first step to a reality where healthcare providers can start reaping the benefits of a larger degree of freedom in choosing what hardware and software to combine, within pathology. This has the potential to increase workflow efficiency, facilitate the adoption of new technology and in the end—benefit patient care,” says Dr. Torbjörn Kronander, CEO and President Sectra AB.

Photo: Sectra