Vieworks ' breast diagnostic imaging solution is making full-scale inroads into North America.
Vieworks, a specialized medical and industrial imaging solutions company (CEO Hu-sik Kim), announced on the 20th that it has obtained premarket approval (510k) from the U.S. Food and Drug Administration (FDA) for its mammography X-ray detectors 'VIVIX-M 1824S' and 'VIVIX-M 2430S'. With this, Vieworks' mammography product line is expected to see significant sales growth as it expands supply to the North American market as well as Europe and South America, regions that have recently shown remarkable growth.
The two products that have been approved this time are flat-panel detectors that can capture X-rays based on still images in the field of digital mammography. They belong to the 'Retro-fit' product group that can easily convert analog X-ray systems (CR) that use film cassettes to digital (DR). Designed to the same specifications as analog cassettes, they enable the establishment of a digital diagnosis system and acquisition of high-quality images without expensive replacement of the entire system.
In terms of performance, it is equipped with the latest panel technology, 'IGZO (indium gallium zinc oxide)' thin film transistor, which enables diagnostic imaging in just 3 seconds with low power, and with a pixel pitch of 75 micrometers, it provides clearer clinical images to help detect microscopic lesions. The product's bezel thickness (chest wall distance) is less than 2 mm, making patient positioning convenient during shooting.
It can also maximize workflow efficiency by linking with 'VXvue Mammo', a dedicated digital mammography image acquisition software. Equipped with 'PureImpact M™', a self-developed advanced image processing algorithm dedicated to breast diagnosis, it corrects major lesions in the breast, such as micro-tumors and calcifications, to make it easier to diagnose, and it is also equipped with a 'gridline preservation' function that preserves image clarity.
Through this, Vieworks' mammography detector product line is currently being supplied to a total of 15 countries including Korea, and has recorded a high average sales growth rate of 100.68% per year since its launch in 2018 until 2023. Furthermore, it is also acquiring a high-resolution X-ray detector lineup for digital breast tomosynthesis (DBT), also known as '3D mammography'. According to the global market research firm 'Grand View Research', the breast cancer diagnosis market is estimated to be approximately KRW 5.9383 trillion as of 2022, and a high growth rate is expected with an average annual growth rate of approximately 7.4%.
Meanwhile, Vieworks' long-form detector 'VIVIX-S 1751S' also recently received pre-market approval (510k) from the FDA in November last year, providing momentum for Vieworks' expansion of its market share in North America.
A Vieworks official said, “Following our recent participation in RSNA 2024 to showcase Vieworks’ core technologies to local officials, we have now received FDA approval for our new long-type detector products and mammography detector products, laying the foundation for actively developing sales channels in North America and increasing our market share.”
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