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Back to directoryAvenda Unfold AI medical AI product profile
AI-based prostate cancer mapping software that combines MRI, biopsy, pathology, PSA, and deep learning to generate patient-specific cancer estimation maps.
Precision medicine and data
Best fit
Prostate cancer teams evaluating a regulated, physician-reviewed mapping input for focal therapy suitability, biopsy planning, ablation planning, or shared treatment decisions.
- Primary use case
- FDA-cleared AI decision-support software for prostate cancer mapping, lesion documentation, biopsy planning, and prostate treatment planning workflows
- Audience
- Urologists, prostate cancer programs, focal therapy teams, radiation oncologists, interventional radiologists, and clinical AI governance teams
- Risk level
- High
- Pricing signal
- Provider, procedure, and reimbursement terms vary; verify current Unfold AI availability, Category III coding, CMS payment status, and contract details.
- Official sources
- 6 official sources
Compare within workflow: Precision medicine and data · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Avenda Unfold AI as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as regulated radiological computer-assisted diagnostic software and match use to K221624 labeling, trained physician use, prostate oncological workflow scope, and any reimbursement-specific requirements. |
|---|---|
| Privacy | Review MRI, biopsy, pathology, PSA, report, and provider-ordering data flows along with privacy-policy terms, BAA coverage, support access, retention, and whether patient data is used for analytics or product improvement. |
| Evidence | Inspect validation evidence for cancer extent mapping, encapsulation confidence, focal therapy planning, MRI-visible and MRI-invisible disease, and performance across local scanners, biopsy approaches, and patient populations. |
| Workflow | Best governed as physician-reviewed prostate cancer decision support with documented image review, biopsy/pathology reconciliation, treatment-planning discussion, patient shared decision-making, and outcomes monitoring. |
Where Avenda Unfold AI fits
Avenda describes Unfold AI as FDA-cleared AI decision-support software that uses standard-of-care prostate MRI, fusion biopsy, pathology, and PSA data to generate a 3D cancer estimation map; FDA 510(k) K221624 covers Avenda Health AI Prostate Cancer Planning Software, and Avenda materials describe U.S. provider availability plus Category III code and CMS payment milestones.
Not for: Standalone diagnosis, autonomous treatment selection, use outside trained physician workflows, or assuming prostate cancer extent without MRI, biopsy, pathology, and clinician review.
What to verify before using Avenda Unfold AI
- FDA 510(k) K221624, current labeling, indications for use, trained-user requirements, and whether the evaluated product version is Unfold AI or an older iQuest-branded release.
- Whether local workflows use the software for lesion segmentation, cancer extent estimation, biopsy planning, focal therapy planning, radiation planning, or follow-up documentation.
- How MRI, fusion biopsy, pathology, PSA, PHI, reports, image outputs, retention, access, support, and BAA or privacy terms are handled.
- Local validation for MRI quality, biopsy approach, tumor location, encapsulation confidence, focal therapy margins, false reassurance risk, and clinician response to the cancer estimation map.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- avendahealth.com / unfold-ai-based-decision-support
- avendahealth.com
- avendahealth.com / press / first-ai-powered-precision-oncology-platform-for-prostate-cancer-care-iquesttm-receives-fda-clearance
- www.accessdata.fda.gov / cdrh_docs / pdf22
- avendahealth.com / press / cms-establishes-national-payment-for-ai-breakthrough-in-prostate-cancer-diagnosis-unfold-ai
- avendahealth.com / privacy-policy
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