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Our aim is to deliver clinically relevant evidence.

From concept to market adoption, we offer Medical and AI expertise to generate clinically relevant evidence for regulated Software as a Medical Device (SaMD) products.

Why choose us?

  • Direct experience and access to clinical and image based diagnostic workflows
  • Deep expertise in validation study planning, design, conduct, and reporting
  • Optimal conveyance of product performance to regulators and users
  • Track record of successful FDA clearance studies

Offerings and capabilities

Validation and regulatory clearance

  • Pre-submission (Q-Sub)
  • Pilot and pivotal study design
  • Scientific publication roadmap
  • Clinical implementation strategy
  • Human factors (usability) assessment

Deployment and clinical integration

  • Standalone performance assessment
  • Image processing/quantification
    • CADt (triage)
    • CADe (detection)
    • CADx (diagnosis)
  • Clinical reader study (CADe, CADx)

Real-world monitoring

  • Ground truth and reads by U.S. board certified sub-specialty physicians
  • Shadow-mode ‘real-world’ performance analysis
  • Clinical workflow impact assessment
  • Patient outcome and economic benefit
  • Monitoring and post-market surveillance with potential for product enhancement
  • Usability and human factors testing