Together, Sectra and Leica Biosystems, Imaging, Inc. have earned the U.S. Food and Drug Administration’s 510(k) clearance to utilize DICOM images in digital pathology diagnostics, the companies announced on Monday.
The clearance, which includes both Sectra’s digital review application and Leica’s Aperio GT 450 DX scanner used together, is the first of its kind from the FDA, marking a significant achievement in the field of pathology. This move has the potential to increase collaboration among care teams, ultimately improving patient care, Elin Kindberg, global product manager for pathology at Sectra, said in a news release.
“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,” Kindberg said. “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.”
Analyzing glass slides containing tissue samples is a time-consuming process. Access to DICOM images of these samples will allow providers to view images remotely when needed, thus improving workflow efficiency when on-site availability is not an option. The demand for such access has grown substantially in recent years, largely fueled by the COVID-19 pandemic.
Although the field of pathology has been migrating toward digital diagnostics for some time, standardization of this process remains an issue, Sectra AB CEO and President Torbjörn Kronander, PhD, said in the announcement.
“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,” Dr. Kronander noted. “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.”
The clearance includes the following:
- 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.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.