ProFound AI (iCAD)
The first AI cleared for 3D mammography in the US, now part of RadNet's imaging network.
Overview
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.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2018 | 510(k) clearance: AI detection for digital breast tomosynthesis (first for 3D mammography) |
| EU | 2019 | CE mark |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- What a result means: the software supports the radiologist reading your 3D mammogram; you are unlikely to be told it was used.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductLunit INSIGHT MMG
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- ProductEndoPredict
Shares HR-positive / HER2-negative breast cancer and the tag test.