Vieworks Secured CE IVDR Certification for Digital Slide Scanner
2025-04-29
Vieworks, a leading provider of biomedical
and industrial imaging solutions, announced on the 29th that its new slide
scanner, The VISQUE DPS (Digital Pathology System) LH510, has successfully
obtained CE IVDR certification for in vitro diagnostic medical devices in
Europe. With this certification, the company is now authorized to distribute
the product within the EU, enabling it to actively target Europe, one of the
key markets in digital pathology diagnostics.
The new VISQUE DPS product has passed all
the stringent requirements imposed by the new in vitro diagnostic medical
device regulations, which have been enforced since May 2022, thereby
demonstrating both the product’s technological strength and the reliability of
its operational system.
Compared to the previous framework, the new
regulations include strengthened technical documentation requirements,
mandatory clinical performance evaluation, and obligatory post-market
surveillance reports. Accordingly, Vieworks conducted actual
clinical performance evaluations to validate product effectiveness and proved
the robustness of its post-market quality management system.
With this certification, Vieworks expects
to accelerate the expansion of its bio business in Europe, following its
progress in the Korean and North American markets, and increase its market
share in the region. Recently, Vieworks has been conducting field tests at
major domestic hospitals after product implementation, and in March, it
introduced the new product to the North American market for the first time at
the USCAP Annual Meeting 2025 held in Boston, where it received positive
feedback.
The VISQUE DPS is a high-speed digital
pathology scanner that reconstructs glass-based tissue slides into
high-resolution whole slide images (WSIs). Designed to handle both tissue and
cytology samples, it delivers top-tier global performance in scanning speed,
image resolution, and maintainability.
The system features Vieworks’ proprietary
Realtime Extended Focus Mod technology, which uses its self-developed
high-resolution camera to capture three images at different focal planes in a
single scan, synthesizing only the sharpest regions into a composite image. The
device can hold up to 510 tissue slides at once and produce 83 WSIs (15x15 mm)
per hour, making it the fastest slide scanner currently available.
A Vieworks representative stated, “By
obtaining the rigorous and demanding CE IVDR certification for in vitro
diagnostic medical devices, Vieworks’ slide scanner has proven its world-class
technological excellence and safety. We will now accelerate our entry into both
the North American and European markets, establishing a foundation for new
growth drivers.”
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Digital Pathology Slide Scanner, VISQUE DPS Product Information
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