Key Features

• ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT) received FDA clearance in November 2024. It uses deep-learning convolutional neural networks and can incorporate a patient's prior exam into current analysis.
• ProFound Detection Version 4.0 showed a 6.3% improved AUC over the prior version, with the vendor separately citing (in its own press materials) specific improvements including 22% better detection of certain aggressive cancer subtypes and reduced false-positive marking rates - these performance percentages are vendor-generated study results cited in press releases, not independently re-analyzed by the trade press reporting on them, so they should be understood as vendor-reported clinical performance data rather than independently audited figures.
• PowerLook Density Assessment provides automated, standardized breast-density scoring, and is also FDA cleared, CE marked, and Health Canada licensed.
• ProFound AI Risk, an image-based breast cancer risk model, is explicitly disclosed by the vendor as CE Marked and Health Canada Licensed but NOT FDA cleared, and available in the U.S. only for investigational use - this is a clear, vendor-stated regulatory limitation rather than a general product claim, and is an important distinction for U.S. buyers to note.
• An earlier version (ProFound AI 3.0 for DBT) received FDA clearance in March 2021, and iCAD's earlier DBT AI technology (PowerLook Tomo Detection) was among the first FDA-cleared for tomosynthesis.

Compliance & Security

• HIPAA Compliance: Not disclosed. A buyer should request HIPAA/BAA documentation directly from iCAD/DeepHealth.
• FDA Status: Cleared (510(k)), on a per-product/version basis. ProFound Detection Version 4.0 (2024) and the earlier ProFound AI 3.0 (2021) and PowerLook Density Assessment are independently confirmed as FDA cleared. ProFound AI Risk is NOT FDA cleared and is available in the U.S. only for investigational use.
• Security certifications: Not disclosed.

Integration & Workflow

• Platform: On-premises/PACS-integrated software (PowerLook platform) reading mammography images via DICOM.

Pricing & Access

• Not publicly listed; the vendor directs prospective customers to "Request a Demo" / "Schedule a Demo" rather than publishing pricing.
• No free trial is advertised on the vendor's public site.

Doxiverse Assessment: Strengths & Limitations

Strengths: iCAD has independently documented FDA-clearance track records in AI-powered mammography. The company was acquired by RadNet's DeepHealth subsidiary, with the acquisition completing on July 17, 2025, which may bring additional institutional scale and resources.

Limitations/Risks: No HIPAA compliance statement or security certification (SOC 2, ISO 27001, HITRUST) was found publicly on iCAD's Compliance page - a real gap for buyers doing security due diligence, especially compared to some peer vendors in this directory that do publish this information; a buyer should request it directly. ProFound AI Risk, the company's newer risk-evaluation product, is explicitly not FDA cleared and available only for investigational use in the U.S. Pricing is entirely non-public.

Ideal User Profile

Best for: Breast imaging centers and radiology practices performing digital or tomosynthesis (3D) mammography screening/diagnostic reads that want an FDA-cleared AI concurrent-reader tool for cancer detection and/or standardized density scoring, particularly those already using one of iCAD's numerous named PACS/imaging-platform integration partners.

Not ideal for: Practices specifically seeking an FDA-cleared AI breast-cancer risk-assessment tool for U.S. clinical (non-investigational) use today.

Disclaimer - This profile was compiled from publicly available sources including the vendor's own website, regulatory filings, press coverage, and independent research. Vendor claims are labeled as such and have not been independently audited by Doxiverse. Product features, pricing, certifications, and regulatory status change frequently and may no longer be current; verify all details directly with the vendor before making a purchasing decision. The "Doxiverse Assessment" and "Ideal User Profile" sections reflect Doxiverse's independent editorial analysis based on available sources at the time of writing, not the vendor's endorsement, and the vendor may disagree with this characterization. This profile is provided for informational purposes only and does not constitute a recommendation, endorsement, or professional/legal/clinical advice. Report inaccuracies to contact@doxiverse.com