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Wearable ECG Validation: FDA Clearance Pathways & Clinical Utility Assessments - Regulatory Impact

Former Associate Director, Clinical Psychology
Pfizer
Digital Health
USA
North America

$ 795

June 18, 2025

Topics covered in this transcript

  • What clinical validation requirements apply to wearable ECG algorithms?
  • How are false positive rates impacting clinical utility?
  • What FDA clearance pathways apply to continuous monitoring claims?
  • How do provider workflows integrate wearable ECG data?
  • What reimbursement challenges exist for consumer-grade devices?
  • How are machine learning models trained on diverse populations?
  • What post-market surveillance tracks real-world performance?
  • How does user compliance affect data reliability?
  • What education materials improve patient interpretation?
  • How are EHR systems adapting to high-frequency ECG data?
  • What cybersecurity protects cloud-stored cardiac data?
  • How do outcomes compare to traditional Holter monitors?

Keywords

  • Wearable ECGs
  • FDA 510(k)
  • Arrhythmia Detection
  • Clinical Validation
  • User Compliance
  • False Positives
  • Provider Workflows
  • Reimbursement
  • Continuous Monitoring
  • Algorithm Training
  • Post-Market Surveillance
  • Consumer Education

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Bangalore

Cinnabar Hills, Embassy Golf Links Business Park, Bengaluru, Karnataka 560071
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Get in touch with us to learn more about our services, ask for assistance with a technical difficulty, or if you would like a product demo.
info@nextyn.com
Singapore
68 Circular Road, #02-01
049422, Singapore
Jakarta

Revenue Tower, Scbd, Jakarta 12190, Indonesia
Mumbai
4th Floor, Pinnacle Business Park, Andheri East, Mumbai, 400093
Bangalore

Cinnabar Hills, Embassy Golf Links Business Park, Bengaluru, Karnataka 560071
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