Volpara Health

By Volpara Health
· New Zealand / USA
Volpara Health — Breast density measurement from mammography.
Diagnostic
Radiology
Production
FDA Cleared
Regulatory status
FDA Cleared
Deployment
Production
Clinical role
Adjunct (decision support)
Headquarters
New Zealand / USA
AI type
Diagnostic

Precise indication

Breast density measurement from mammography.

Regulatory status

Multiple FDA clearances confirmed, including a next-generation breast-density algorithm and architecture.

Clinical evidence

Vendor-supported

Vendor press release for the FDA clearance.

Independent

Not found in this research pass — verify before publishing.

Real-world deployment

Self-described as a market leader in AI-assisted breast density measurement; no independent figure found.

Interoperability

European status

Editorial verdict

Limits and uncertainties

Market-leadership claim is vendor-sourced, not independently verified in this pass.

Sources

https://www.volparahealth.com/news/volpara-health-receives-fda-clearance-for-next-generation-breast-density-algorithm-and-architecture/

This profile is not medical advice or an endorsement. Hospitals should perform their own due diligence (regulatory compliance, GDPR, cybersecurity, integration, local clinical validation). How we evaluate

At a glance
Vendor
Volpara Health
Headquarters
New Zealand / USA
AI type
Diagnostic
Specialty
Clinical role
Adjunct (decision support)
CE marking
Notified body
EU AI Act
Data hosting
Last verified
Reviewed by
How we evaluate

Every profile documents the precise indication, regulatory status, vendor-supported and independent evidence, real-world deployment, limits and dated sources.

A independent systematic review or prospective multicentre study · B at least one independent peer-reviewed study · C peer-reviewed, vendor-supported · D vendor claims only.

Read the methodology →

Spotted an error?

Vendors, authors and clinicians can request a correction. Corrections are dated on the profile.