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Mammography detector lineup receives FDA 510(k) clearance

2025-01-20



Vieworks Expands Digital Mammography Solutions into North America

 

Vieworks, a leading provider of imaging solutions, announced today that it has received premarket notification (510(k)) clearance from the U.S. Food and Drug Administration (FDA) for the VIVIX-M 1824S and VIVIX-M 2430S X-ray detectors for mammography. This expands the availability of Vieworks' mammography product line to the North American market, in addition to Europe and Latin America, where the company has experienced strong growth in recent years and expects significant revenue growth.

 

The two cleared products are flat panel detectors that enable static image-based acquisition of X-rays in digital mammography applications. They are part of a 'retrofit' lineup that allows analog X-ray systems using film cassettes (CR) to be easily converted to digital (DR). Designed to match the specifications of analog cassettes, they enable digital diagnostics and superior image quality without the need for costly full system replacement.

 

In terms of performance, the latest panel technology, IGZO (Indium Gallium Zinc Oxide) thin-film transistors, enables diagnostic imaging in three seconds with low power consumption, while the 75-micrometer pixel pitch delivers clearer clinical images to help detect small lesions. Moreover, the device has a chest wall distance of less than two millimeters for easy patient positioning during imaging.

 

It also works with VXvue Mammo, a dedicated image acquisition software for digital mammography, to maximize workflow efficiency. PureImpact M™, an advanced image processing algorithm developed in-house for breast diagnostics, enhances the diagnosis of major breast lesions, such as microtumors and calcifications, and features a gridline preservation function for improved image clarity.

 

Since its launch in 2018, Vieworks' mammography detector product line has achieved a CAGR of 100.68% and is now available in 15 countries. Furthermore, the company is building a lineup of high-resolution X-ray detectors for Digital Breast Tomosynthesis (DBT), also known as 3D mammography.

 

“Following our successful participation in RSNA 2024, where we showcased our core technologies, we are pleased to announce FDA clearance for our new long-format and mammography detectors. This milestone positions us to expand into the North American market and enhance our market share,” said a Vieworks representative.

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Mammography detector lineup VIVIX-M series product information


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