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Clinical Trials for Wearable & AI-Driven Diagnostic Devices

Accelerate Regulatory Success for Innovative Diagnostic Technologies

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The Rise of Wearable and AI Diagnostics

Artificial intelligence and sensor-enabled wearables are transforming how we detect, monitor, and manage health conditions. These technologies offer real-time, non-invasive insights across cardiology, neurology, oncology, metabolic disorders, and more.

Common applications include:

  • Continuous monitoring of cardiac function, glucose, or respiratory patterns
  • Early detection of stroke, arrhythmias, or tumor progression
  • Predictive analytics for post-op recovery or chronic disease management
  • AI-powered pathology/imaging platforms to support clinical decisions

To bring these innovations to market, device companies must demonstrate clinical performance, usability, and patient safety in well-designed studies that meet FDA and international regulatory standards.

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Our Clinical Trial Services for Wearable & AI Diagnostic Devices

Regulatory & Feasibility Strategy

  • Determine clinical trial classification (IDE, PMA, De Novo, or 510(k))
  • Assess FDA expectations and international pathways (e.g., MDR, IVDR)
  • Develop strategy for Breakthrough Device Designation or SaMD review

Protocol & Documentation Development

  • Design efficient, patient-centric clinical protocols
  • Prepare essential documents (Informed Consent, CRFs, IRB/REB packages)
  • Support AI algorithm change control strategy

Site Selection & Trial Execution

  • Conduct site feasibility and investigator recruitment
  • Oversee site training, enrollment, and monitoring
  • Ensure real-time data integrity and device usability feedback

Data Management & Biostatistics

  • Custom database design for wearable or software-generated data
  • Conduct interim and final statistical analyses
  • Align output with FDA, ISO 14155, and MDR expectations

FDA & Health Canada Engagement

  • Prepare Pre-Subs and lead communications with FDA/CDRH or Health Canada
  • Support Q-Sub meetings and real-time feedback on protocol/data expectations

Why Choose dicentra?

  • Over 20 years of clinical and regulatory experience in medical devices
  • Global reach: North America, Europe, and Asia
  • Proven success with AI software, connected devices, and diagnostic endpoints
  • CRO + Regulatory + Reimbursement services under one roof

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