A new clinical study aims to compare the accuracy and consistency of a portable patch-type carotid ultrasound device, CADFlow, with traditional desktop ultrasound machines in monitoring hemodynamic parameters. Sponsored by Xuzhou Medical University Affiliated Suqian Hospital, the trial highlights advancements in wearable medical technology and its implications for diagnostic practices. Professionals in clinical research, regulatory affairs, and quality assessment should follow developments closely.
In this article:
- Why is this study important?
- What are the details of the study?
- What are the regulatory implications?
- FAQ
- Conclusion
- Disclaimer
- Source link for details
Why is this study important?
The trial explores the evolving landscape of wearable medical devices, particularly in diagnostic applications. With an increasing adoption of portable technologies in clinical settings, demonstrating reliability is critical for broader acceptance by practitioners and regulators. CADFlow’s potential to reduce reliance on stationary ultrasound machines could improve access and efficiency in monitoring hemodynamic changes.
What are the details of the study?
Conditions and Interventions
The study focuses on device replacement scenarios in hemodynamic monitoring. It involves evaluating CADFlow against traditional desktop models under diagnostic test protocols to assess their consistency and accuracy.
Status and Sponsorship
As of September 2025, the clinical trial is not yet recruiting participants. It is sponsored by Xuzhou Medical University Affiliated Suqian Hospital, an institution known for pioneering medical device trials. Researchers and developers in medical diagnostics should monitor recruitment updates for participation opportunities.
What are the regulatory implications?
Insights gained from this comparative study may guide regulatory expectations for wearable diagnostic devices. Authorities typically assess devices based on MDR Annex XIV requirements, focusing on safety, performance, and intended use. Positive results might influence market access strategies for similar ultrasound technologies.
FAQ
1. When will recruitment begin?
The trial is marked as “Not Yet Recruiting.” Follow updates from ClinicalTrials.gov.
2. Who is sponsoring the trial?
Xuzhou Medical University Affiliated Suqian Hospital sponsors this study.
3. What devices are under evaluation?
The study compares CADFlow, a portable carotid ultrasound patch, with desktop ultrasound machines.
Conclusion
Reliable performance data will be vital for regulatory submissions of wearable ultrasound devices. Advances could reshape diagnostic applications by providing accessible and efficient alternatives to desktop solutions. Stakeholders in regulatory affairs, device development, and clinical workflows should prepare for outcomes that impact the market landscape.
Disclaimer
This blog post is for informational purposes only. It does not constitute legal advice. Always consult regulatory experts for compliance matters.
Source link for details
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07197411?term=medical+device