Summary: Sectra’s digital pathology solution, developed with Leica Biosystems Aperio GT 450 DX, has obtained U.S. FDA clearance, marking the first approval for DICOM images in pathology diagnostics.

Key Takeaways:

  1. Sectra’s partnership with Leica Biosystems Aperio GT 450 DX marks the inaugural FDA approval of DICOM images for pathology diagnostics.
  2. The pandemic sped up Sectra’s first FDA approval, showing the increasing need for digital pathology solutions worldwide and in the U.S., driven by remote work and the necessity for efficient image sharing and review.
  3. The FDA clearance process affirms Sectra’s solution quality, facilitating the use of advanced scanner technology and standardized practices in pathology departments for better patient care, particularly in complex cases like cancer.


Sectra’s digital pathology solution, in collaboration with Leica Biosystems Aperio GT 450 DX, has secured U.S. FDA 510(k) clearance, marking the first time DICOM images are approved for pathology diagnostics.

Surge in Digital Pathology Demand

In 2020, Sectra received its first FDA approval. This coincided with the pandemic, highlighting the importance of remote work in pathology, and boosting digital pathology adoption in the US. Now, there’s a clear demand for sharing and reviewing digital images, driving rapid growth in the U.S. and global digital pathology market.

“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.

Inside the FDA Clearance

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.

“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,” says Sectra AB President and CEO Torbjörn Kronander, PhD, MSEE, MBA. “Due to the unique nature of the images used in digital pathology, proprietary formats have previously dominated.”

Kronander adds, “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 more 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.”