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The first AI cleared for 3D mammography in the US, now part of RadNet's imaging network.
iCAD's ProFound AI was cleared by the FDA in December 2018 as the first artificial-intelligence software for digital breast tomosynthesis, and later versions cover 2D mammography, breast density and risk. The company's reader study reported faster reading and improved sensitivity for radiologists using the software. iCAD, based in Nashua, New Hampshire, agreed in 2025 to be acquired by RadNet, which also owns DeepHealth (and, through it, Kheiron), consolidating three of the leading mammography AI products under one imaging chain. ProFound is installed at thousands of sites in the US and Europe.
Deep-learning detection across the slices of a tomosynthesis exam or a 2D mammogram, with case and lesion scores for radiologists.
1.ProFound AI (iCAD) slips into a pocket on its target.
| Region | Year | Indication |
|---|---|---|
| US | 2018 | 510(k) clearance: AI detection for digital breast tomosynthesis (first for 3D mammography) |
| EU | 2019 | CE mark |
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Query for this drug: (TITLE:"ProFound AI" OR ABSTRACT:"ProFound AI" OR TITLE:"iCAD" OR ABSTRACT:"iCAD" OR TITLE:"ProFound Detection" OR ABSTRACT:"ProFound Detection") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about ProFound AI (iCAD), not a curated reading list.
Shares Mammography & tomosynthesis, AI in radiology, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Mammography & tomosynthesis, AI in radiology, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Mammography & tomosynthesis, AI in radiology, Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares AI in radiology and the tag test.
Shares Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.
Shares Triple-negative breast cancer (TNBC), HR-positive / HER2-negative breast cancer and the tag test.