Build Trust and Compliance in Medical Imaging AI
Automated validation, continuous monitoring & FDA- grade compliance for safe and effective AI adoption.
Whatever AI you use, however you deploy it – marketplace, PACS, or home-grown – Radinate provides the independent layer of assurance, comparison, and regulator-ready reporting on top.
See Radinate in Action
Watch a walkthrough of how Radinate ingests model outputs, applies FDA-compliant risk logic, and generates dashboards and regulator-grade reports for hospitals, vendors and oversight bodies.
Use this demo in conversations with CMIOs, quality leaders and AI vendors to show how continuous validation and governance can be built into the AI product lifecycle from day one.
Request Full DemoWhy It Matters
Healthcare organizations are being told to "trust but verify" AI, with FDA, the Joint Commission, and AMA calling for local validation, continuous monitoring, and governance. However, most hospitals rely on one-off trials and ad-hoc audits that don't scale and can miss performance drift or bias.
Meanwhile, AI vendors only monitor models on their own platforms, creating siloed oversight. Radinate bridges this gap by aggregating and standardizing performance monitoring across all AI tools, ensuring continuous validation throughout the AI lifecycle.
From Point-in-Time to Continuous
Move beyond one-month pilots and sporadic audits. Radinate turns post-market monitoring into an automated, always-on process for safety, effectiveness and equity.
Vendor-Neutral, Cross-Vendor Oversight
Compare models from different vendors side-by-side, run site-specific bake-offs, and see real-world performance across patient cohorts, scanners and sites in one place.
Regulator-Grade Reporting
Aligns with FDA PCCP compliance, the Joint Commission-CHAI regulatory guidance of responsible AI, so the same evidence that keeps patients safe also prepares you for regulators and accreditors.
Platform Features
Radinate sits as an independent "trust layer" behind your existing AI deployment stack – marketplaces, PACS, and cloud pipelines. We don't replace your infrastructure; we make it governable.
Governance & Policy Engine
Configure FDA/AMA style policies (e.g. "no AI without local bias testing") and let Radinate automatically verify incoming vendors against those requirements.
Dynamic Risk Scorecard
Convert model information and outputs into a dynamic risk score, highlighting mismatches between vendor "intended use" and your actual use, populations or care settings.
Bias Radar & Demographic Alignment
Compare vendor training data demographics with your own patient census to flag representativeness gaps and equity risks before rollout.
PCCP & Lifecycle Monitoring
Track model changes, retraining events and performance deltas over time, linking them to your PCCP commitments and audit-ready documentation.
Sentinel Event & Safety Hub
Standardised, blinded safety reporting mapped to your patient safety framework, turning frontline feedback into structured, actionable signals.
PACS & Marketplace Integration
Connect to PACS, VNAs and AI marketplaces to ingest outputs and metadata without pulling PHI out of your environment, enabling compute-to-data architectures.
Our Services
Alongside the platform, we partner with you to stand up AI governance quickly – from the first pilot to enterprise-wide rollout.
Our validation pilot
Short, high-impact validation projects that mirror real clinical workflows: version-to-version comparisons, AI on/off analyses and bias lenses (age/machine/site).
Enterprise AI Governance Design
Help your AI governance committee translate FDA, Joint Commission and AMA regulatory guidance on responsible AI use into concrete policies, workflows and dashboards in Radinate.
PACS /EMR Integration
Integration support for PACS, EMR and modalities configuring DICOM and HL-7 routing, ground truth comparison and connecting them to Radinate's monitoring without disrupting clinicians.
In Partnership With
Built on trusted AI & cloud foundations
Radinate leverages NVIDIA Inception for advanced AI tooling and optimization, and AWS for secure, scalable cloud infrastructure. Together, they help us deliver hospital-grade performance, reliability, and compliance out of the box.
Contact Us
Ready to bring continuous validation and governance to your medical imaging AI? Reach out to explore pilots, integrations or strategic partnerships.
Email us directly at contact@radinate.com or use the form below.
Prefer to talk directly? Email us and we'll respond within 24 hours.