Radiology · Breast tomosynthesis CAD
ProFound AI for Digital Breast Tomosynthesis
iCAD (DeepHealth / RadNet)
ProFound was the first AI cleared by the FDA for 3D tomosynthesis, and six years of clearances — V2.1 in 2019 through ProFound Detection V4.0 in 2024 — have kept it among the most widely deployed breast-CAD tools, at 1,500-plus provider sites. Its pivotal evidence is a manufacturer-authored multireader study in which radiologist AUC rose from 0.795 to 0.852 with a 52.7 percent cut in reading time. The honest caveat is design: that pivotal study is an enriched retrospective reader study, and the strongest independent comparison to date placed ProFound below human double-reading — which holds the platform at two marks rather than three.
Performance Metrics
Clinical Evidence
ProFound AI's evidence base is anchored by a manufacturer-authored multireader, multicase reader study (Conant et al., Radiology: Artificial Intelligence 2019;1:e180096): 24 radiologists, 13 of them breast subspecialists, read an enriched set of 260 DBT cases (65 cancers) with and without the software. Mean radiologist AUC rose from 0.795 unassisted to 0.852 assisted; sensitivity improved by roughly 8 percentage points, recalls and false positives fell by about 7 percent, and reading time dropped 52.7 percent. The study is the basis for the V2.1 clearance and remains the most cited ProFound evidence, but it is an enriched, retrospective reader study, not a prospective screening trial, and was funded by the manufacturer. Independent evidence is more measured. A 2024 comparative study from a Vienna and Memorial Sloan Kettering group (Radiology: Imaging Cancer 2024) evaluated ProFound AI 3.0 alongside another commercial system and benchmarked both against radiologists: both AI systems performed well in absolute terms but below human double-reading, a result worth carrying honestly given how often AI-CAD is framed as a replacement for the second reader. Broader independent meta-analysis of DBT AI (Radiology 2023) reports favourable pooled accuracy for the device class without being ProFound-specific. A real-world series (Journal of Breast Imaging 2023) reported a non-significant cancer-detection difference (7.3 vs 5.9 per 1,000) in early deployment. The throughput case is consistent and the detection case is real but assistive: ProFound raises radiologist accuracy and materially shortens reading time in reader studies, while the best independent head-to-head evidence positions it as a concurrent aid that does not yet match double human reading. The Certainty of Finding and Case Score outputs are confidence indices, not calibrated malignancy probabilities, and should be read as such.
| Study | Design | n | Sensitivity | Specificity | AUC | Published |
|---|---|---|---|---|---|---|
| Conant EF, Toledano AY, Periaswamy S, et al. (MRMC, 24 radiologists) | RetrospectiveRetrospective | 260 | +8 pts assisted | — | 0.852 assisted vs 0.795 unassisted | Radiology: Artificial Intelligence, Jul 2019; reading time -52.7% |
| Independent comparative evaluation (Vienna / Memorial Sloan Kettering) | RetrospectiveRetrospective | 0 | 100% at rule-out <51 | 67% at rule-out <51 | — | Radiology: Imaging Cancer, 2024; ProFound AI 3.0 below human double-reading |
| Real-world DBT screening series | RetrospectiveRetrospective | 0 | — | — | — | Journal of Breast Imaging, 2023; CDR 7.3 vs 5.9 per 1,000 (non-significant) |
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Inside the Auris+ Listing
Six more sections complete this device’s Auris+ Listing.
Inside the algorithm
ProPro unlocks the five-stage editorial walkthrough of how this device's AI reaches a verdict — model architecture, training data, inference latency, and where the clinician stays in the loop.
Decision Ledger
ProPro unlocks a private, cross-vendor log of every case you read on this device — what the AI called, what you concluded, and a one-line reason if you overrode it. Ready for the EU AI Act's deployer logging obligations when they land in 2028.
Clinical Evidence Deep Dive
ProPro unlocks the structured clinical-evidence summary — study count, target patient population, and a tabular accuracy-metrics view drawn from peer-reviewed sources.
Peer-Reviewed Publications
ProPro unlocks the curated peer-reviewed publication list with PubMed cross-links — the citation backbone of every editorial verdict.
Post-Market & Regulatory Conditions
ProPro unlocks the post-market surveillance summary, recall record, and the conditions of approval that bound real-world use.
AI Algorithm Version History
ProPro unlocks the chronological record of algorithm version changes — what changed when, drawn from manufacturer changelogs and regulatory filings.
Regulatory Approvals
K240417
Class II
Class IIa (MDD)
Safety Record
No ProFound AI recall or FDA safety communication was identified in publicly available sources as of June 2026; this should be read as "none found in public reporting" rather than an exhaustive MAUDE audit, which could not be queried directly from this environment. A name-collision caveat matters here: adverse-event reports filed under the brand "ProFound" in MAUDE belong to a radiofrequency aesthetic device (Candela/Syneron ProFound), not to iCAD's mammography software, and must not be attributed to this product. As a concurrent-read CAD overlay the device does not remove studies from the worklist or alter the source images, which limits its harm surface; the principal documented risk is over-reliance on a low Case Score, since a negative output does not exclude malignancy.
Intended Use & Indications
ProFound AI (cleared lineage: PowerLook Tomo Detection V2 → ProFound AI Software V2.1 → V3.0 → ProFound Detection V4.0) is a Class II radiological computer-assisted detection and diagnosis device (21 CFR 892.2090, product code QDQ) intended for concurrent use during interpretation of digital breast tomosynthesis exams. The software identifies and marks suspicious soft-tissue densities and calcifications in the tomosynthesis planes, assigns each detected region a Certainty of Finding percentage and the case an overall Case Score, and presents these to the reading radiologist alongside the standard read. The Case Score is a confidence index, not a calibrated probability of malignancy. Final diagnostic and management decisions remain with the interpreting physician. The marketed family also includes a separate ProFound AI for 2D Mammography product (CE-marked, not FDA-cleared) and ProFound Risk, a 1–2 year breast-cancer risk model that is distinct from the detection product and is not FDA-cleared in the US.