LINKÖPING, Sweden, April 29,
2024 /PRNewswire/ -- 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 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.
"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.
The FDA clearance includes:
- Sectra's digital pathology solution when used with Leica
Biosystems Aperio GT 450 DX
- SVS and DICOM file formats
- 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. 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.
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.
Learn more about Sectra's digital pathology solution
>>
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. Visit
Sectra's website to read more about Sectra and why it's top-ranked
in "Best in KLAS".
About Sectra
Sectra contributes to a healthier and safer society by assisting
health systems throughout the world to enhance the efficiency of
care, and authorities and defense forces in Europe to protect society's most sensitive
information. The company, founded in 1978, is headquartered in
Linköping, Sweden, with direct
sales in 19 countries, and distribution partners worldwide. Sales
in the 2022/2023 fiscal year totaled SEK
2,351 million. The Sectra share is quoted on the Nasdaq
Stockholm exchange. For more information, visit Sectra's
website.
For further information, please contact: Dr.
Torbjörn Kronander, CEO and President Sectra AB, 46 (0) 705
23 52 27
Marie Ekström Trägårdh, Executive Vice President Sectra AB and
President Sectra Imaging IT Solutions, 46 (0)708 23 56 10
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Sectra's digital
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