FDA-Cleared AI for Enhanced Medical Diagnostics

Chroma Vision's FDA-cleared medical imaging AI radically transforms diagnostic accuracy and efficiency. Our clinically validated solutions integrate seamlessly into existing healthcare workflows, empowering radiologists to detect critical findings faster and more consistently, ultimately improving patient outcomes.

FDA Cleared Badge for Medical Device

Clinically Validated & FDA Cleared

  • 98.7% Sensitivity: Proven critical finding detection in validated clinical trials.
  • 40% Reduced Turnaround: Optimize diagnostic workflows while maintaining quality.
  • HIPAA Compliant: Enterprise-grade security and regulatory adherence.
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Radiologist reviewing AI-enhanced medical images on a screen
A radiologist examining a medical scan with AI overlay for diagnostic support.

Comprehensive Medical Imaging Applications

Chest X-ray Analysis

Advanced AI for rapid detection of pneumonia, tuberculosis, COVID-19, and other pulmonary abnormalities, aiding timely intervention.

CT & MRI Interpretation

Precise analysis of neurological conditions, tumor detection, and trauma assessment for critical diagnostic speed. Visual heatmaps highlight regions of interest.

Mammography Screening

Early and accurate breast cancer detection with AI-assisted mammography analysis, reducing false positives and improving patient outcomes.

Retinal Imaging

Automated detection of diabetic retinopathy, glaucoma, and other ophthalmologic conditions, supporting preventative care.

Pathology Slide Analysis

Expedited cancer detection and tissue classification from digital pathology slides for enhanced diagnostic precision.

Musculoskeletal Imaging

AI-powered analysis of X-rays and MRI for orthopedic diagnostics, fracture detection, and degenerative joint disease assessment.

AI interface showing a medical scan with highlighted regions and a confidence score
A sophisticated AI diagnostic interface demonstrating transparent confidence scoring.

Explainable AI with Clinical Confidence Scoring

Chroma Vision believes in transparent AI. Our solutions provide clear, explainable diagnostic recommendations coupled with robust confidence scores, empowering clinicians with verifiable insights and enhanced decision-making.

  • Transparent Rationale

    Understand the AI's reasoning behind every diagnostic suggestion, fostering trust and facilitating clinical review.

  • Risk Stratification

    Prioritize urgent cases with AI-driven risk assessment, optimizing radiologist workload and ensuring critical findings are addressed promptly.

  • Visual Heatmaps & ROIs

    Instantly visualize regions of interest and diagnostic evidence directly on the medical images.

Seamless Healthcare System Integration

Our AI tools are engineered for effortless interoperability, ensuring a smooth transition into your existing clinical environment and enhancing workflow efficiency without disruption.

PACS Integration

Automated image analysis and direct result reporting into your Picture Archiving and Communication System.

EHR Connectivity

Structured diagnostic reports and documentation flow directly into Electronic Health Records.

HL7 FHIR Compliance

Ensuring robust interoperability with all modern healthcare information systems through industry standards.

Workflow Optimization

Prioritized worklist management and smart task allocation to streamline radiologist operations.

QA Dashboards

Monitor AI performance and clinical outcomes in real-time, driving continuous improvement.

Billing & Coding Support

Facilitate accurate billing and coding for AI-assisted diagnostic procedures, maximizing reimbursements.

Diagram illustrating seamless integration of AI into a clinical workflow with PACS, EHR, and Teleradiology
Simplified visual of Chroma Vision AI integrating into a typical healthcare ecosystem.

Proven Clinical Outcomes and Evidence

Chroma Vision's commitment to clinical excellence is backed by rigorous multi-site validation studies and peer-reviewed publications. Our AI consistently demonstrates tangible improvements in patient care and operational metrics.

+30%

Earlier Detection Rates

Leading to earlier treatment initiation and improved prognoses across various conditions.

2.5x

Radiologist Productivity

While maintaining or exceeding diagnostic quality and accuracy standards.

-20%

Healthcare Cost Reduction

Through optimized workflow, resource utilization, and reduced re-imaging.

<1%

Diagnostic Error Reduction

Achieving greater consistency and minimizing human-factors related errors.
Medical professionals reviewing graphs and data on a large screen, symbolizing clinical evidence and improved outcomes
A team analyzing clinical trial data on a dashboard, showcasing positive patient outcomes and efficiency gains.

Unwavering Commitment to Compliance and Security

Chroma Vision is built on a foundation of rigorous security and adherence to global healthcare regulations, ensuring patient data integrity and trust. Your data's safety is our highest priority.

HIPAA Compliant

End-to-end encryption and secure handling of all Protected Health Information (PHI).

FDA Quality Systems

Adherence to FDA quality system regulations and robust post-market surveillance protocols.

SOC 2 Type II Certified

Independent assurance of our security, availability, processing integrity, confidentiality, and privacy.

BAA Agreements

Comprehensive Business Associate Agreements in place for secure data processing.

Audit Trails & Logging

Detailed audit trails and logging for full transparency, regulatory compliance, and quality assurance.

Global Compliance

Achieving international standards including CE marking and Health Canada approval.

Abstract representation of secure data flow and regulatory compliance with glowing blue lines and secure lock icons
Visualizing our robust security framework and adherence to global compliance standards.

Expert Clinical Implementation and Continuous Support

Chroma Vision partners with your institution every step of the way, from initial workflow assessment to ongoing optimization, ensuring seamless AI integration and maximizing its clinical benefits. Our dedicated team is committed to your long-term success.

  • Workflow Assessment

    Thorough analysis of your current clinical environment to identify optimal AI integration points and efficiencies.

  • Radiologist Training & Change Management

    Comprehensive training programs and strategic support to ensure smooth adoption and proficient utilization by clinical staff.

  • Ongoing Clinical Support

    Dedicated support teams and performance monitoring ensure continuous optimization and maximize your AI investment.

Discuss Your Implementation Roadmap
Medical team collaborating around a digital display, symbolizing implementation and support
Healthcare IT specialists and medical staff working together to implement new AI systems.

Ready to Advance Your Diagnostic Capabilities?

Connect with Chroma Vision today to explore how our FDA-cleared AI solutions can transform your medical imaging workflow and patient care outcomes.

Schedule a Clinical Demonstration Now