FDA Compliance, Privacy Policy and Terms of Use
FDA & Regulatory Compliance Notice
Regulatory Status: The software, technologies, and analytical methods described on this website (including LaminaFlow) represent investigational and analytical software tools currently undergoing regulatory review and development.
Unless explicitly stated otherwise for specific commercial modules, these tools have not yet received formal clearance or approval from the U.S. Food and Drug Administration (FDA) under Section 510(k) or Premarket Approval (PMA) pathways for diagnostic or therapeutic use.
Intended Use Disclaimer: Information provided on this platform is intended solely for general informational, educational, and preliminary analytical demonstration purposes. It is not intended to serve as a substitute for professional medical advice, diagnosis, or treatment, nor should it be relied upon as a primary clinical decision-making tool.
Arterial Dynamics, LLC is committed to data privacy, intellectual property protection, and regulatory transparency.
1. Privacy Policy
- Data Collection: We do not collect personally identifiable information (PII) unless you voluntarily provide it via our contact form or direct email inquiries.
- Data Use: Information submitted through this site is strictly used to respond to research inquiries, partnership requests, and clinical communications. We never sell, rent, or trade user data.
- Analytics: Basic non-identifiable web traffic metrics may be logged automatically to maintain site performance and security.
2. Intellectual Property & Proprietary Technology
- IP Protection: All text, visual schematics, microfluidic architecture descriptions, and technical concepts on this site (including LaminaFlow™ separation technology) represent proprietary intellectual property of Scientific Illustration Services / Arterial Dynamics.
- Unauthorized Use: Reproduction, reverse-engineering, or unauthorized distribution of proprietary materials is strictly prohibited.
3. Informational Purpose & Regulatory Status
- Non-Diagnostic Notice: Content on this website is provided for research, institutional partnership, and educational purposes only. It does not constitute medical advice, clinical diagnosis, or treatment directives.
- Developmental Status: Descriptions of technical platforms, including microfluidic core designs and regulatory pathways (such as the FDA Breakthrough Devices Program), reflect ongoing development and pre-submission objectives. Devices and software remain subject to final verification, testing, and regulatory clearance.
4. Contact Information
For questions regarding site administration, legal notices, or data handling, contact:
Email: [email protected]
Address: 1019 8th Street, Suite 107, Golden, Colorado, 80401, USA