Key Features

• Detects and localizes BAC segments at the study and breast level on both FFDM and DBT screening mammograms
• Displays results on a "cmAngio Scorecard" with thumbnail images and contours highlighting identified BAC regions
• Reports an AUC of 0.98 across combined DBT and FFDM cases. This figure is sourced to FDA submission K250754, "performance data on file", but it also has independent, peer-reviewed corroboration: a PLOS Digital Health study and a JACC: Advances study both report AUC 0.98 with 94% sensitivity and 96% specificity. Note: these published studies used earlier training/validation cohorts (20,000–34,000+ mammograms from 13 facilities in Australia, Brazil, and the U.S.) rather than the specific dataset underlying the K250754 submission.
• Cloud-based, PACS-agnostic architecture; it requires no on-site hardware and integrates via a "cmEdge Client" that transmits staged, anonymized DICOM data to the cloud
• Cleared for screening mammograms in women aged 40–90.

Compliance & Security

• HIPAA Compliance: the platform is HIPAA compliant.
• FDA Status: Cleared. The original clearance, K232367 for cmAngio V1.0, was granted in October 2023 for BAC detection and localization on Hologic FFDM and DBT systems, classified as a Class II device under product code QIH. A subsequent 510(k), K250754 (for cmAngio V1.6), expanded clearance to GE image acquisition systems in April 2025; the clearance letter also notes the device is intended to aid, not replace, a qualified interpreting physician, is not intended for primary breast cancer interpretation, and its results should not be used alone for diagnosis or treatment decisions. This is a non-diagnostic, adjunctive detection tool rather than a stand-alone diagnostic device.
• A next-generation "V2.0" is in FDA review with a 510(k) pending, expected in 2026.
• Security certifications: cmAngio is "ISO 13485 compliant" and "MDSAP compliant" (Medical Device Single Audit Program).
• International status: cmAngio holds ANVISA (Brazil) regulatory notification No. 81464750139, originally issued in March 2024 for V1.0, and updated in April 2026 to cover V1.6 and expanded modality support.

Integration & Workflow

• Compatible mammography systems: Hologic and GE image acquisition systems
• Platform: Cloud-based SaaS; it is PACS-agnostic and requires no new hardware or software integration on-site, with DICOM data routed through a "cmEdge Client."
• Onboarding: Implementation follows a 4-week structured process- foundational stakeholder alignment (week 1), technical deployment and reporting template setup (week 2), staff education and end-to-end workflow validation (week 3), and go-live (week 4).
• Not publicly disclosed: specific EHR integrations (e.g., Epic, Cerner) beyond mammography acquisition systems.

Pricing & Access

Pricing is not publicly listed. The vendor's site directs prospective customers to request a demo, with no published per-exam, subscription, or licensing figures found in any source reviewed. No free trial is mentioned; the vendor offers a personalized demo request process, with a stated 24-hour response commitment.

Doxiverse Assessment: Strengths & Limitations

Strengths:

FDA clearance is independently confirmed through the FDA's own 510(k) database, for a specific, well-defined use case (BAC detection/localization) with clear regulatory scoping language limiting its intended use.
The 0.98 AUC figure has meaningful independent support: it is corroborated across multiple peer-reviewed publications (PLOS Digital Health, JACC: Advances, an AHA Circulation abstract). Though those studies used different training cohorts than the specific FDA submission data.
The tool piggybacks on an existing screening exam without additional radiation or procedures for the patient. The vendor claims cmAngio is live in 400+ U.S. clinical sites, though this figure is vendor-reported and not independently verified.

Limitations/Risks:

Modality lock-in: clearance is currently limited to Hologic and GE acquisition systems; sites using other mammography equipment may not be supported.
While the 0.98 AUC has peer-reviewed corroboration, the specific dataset underlying the K250754 FDA submission itself is described by the vendor only as "data on file" and has not been separately published. Buyers should still ask CureMetrix directly for the submission-specific study methodology and population before relying on the figure for procurement decisions.
No publicly available pricing makes upfront cost comparison against competing tools difficult without a direct sales conversation.
BAC has no established national reporting guideline, meaning adoption of cmAngio's output into clinical practice may still require an institution to build its own referral/reporting pathway rather than following a standardized protocol.

Ideal User Profile

Best for: Breast imaging centers and radiology groups performing routine screening mammography (FFDM or DBT) on Hologic or GE equipment that want to add cardiovascular risk screening value to an existing exam without new hardware.
Not ideal for: Sites using mammography equipment outside the Hologic/GE-cleared scope, or practices seeking a diagnostic (rather than adjunctive/incidental-finding) AI tool, since cmAngio's FDA clearance explicitly excludes primary breast cancer interpretation.

Disclaimer - This profile was compiled from publicly available sources including the vendor's own website, regulatory filings, press coverage, and independent research as of July 2026. 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