GE HealthCare’s Pristina Recon DL tool has received pre-market authorisation (PMA) from the US Food and Drug Administration (FDA).
Recon DL is a 3D mammography image reconstruction technology available as an upgradeable feature on GE HealthCare’s Pristina Via platform. It uses two deep learning (DL) models in tandem to separate meaningful signals from noise in mammography images.
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GE HealthCare claims that Recon DL is the first mammography technology to use deep learning in combination with iterative reconstruction to improve digital breast tomosynthesis (DBT) image quality.
The first DL model reconstructs 3D volumes to minimise artifacts while the second is trained to improve the visualisation of ‘clinically relevant’ information into a synthesised 2D view.
A GE HealthCare study that supported the PMA submission with the FDA showed that Recon DL’s overall image quality was preferred by breast radiologists in 99.1% of the image reviews compared to previous DBT reconstruction tools.
The tool also performed strongly in the detection of microcalcification clusters and masses, as demonstrated in a trial with modelled clinical data.
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By GlobalDataGE HealthCare’s women’s health and X-ray president and CEO Jyoti Gupta commented: “By applying advanced deep learning technologies, we’re shaping the future of breast imaging – one defined by uncompromised image quality, faster workflows, and greater confidence in early cancer detection.”
GE HealthCare said it has worked with academic institutions and imaging centres to develop and validate the algorithms used in Recon DL throughout its development process.
Research from the National Cancer Institute (NCI) indicates that breast cancer remains one of the most common cancers among women, with one in eight expected to face a diagnosis in their lifetime.
According to GlobalData analysis, the global mammography equipment market, a subcategory of the broader diagnostic imaging market, is growing at a CAGR of 4.9% and forecast to reach a valuation of almost $4bn by 2034, up from $2.4bn in 2024.
In January, Siemens Healthineers began to the first installations of its Mammomat B.brilliant, a mammography system that also features 3D image reconstruction technology.
