Disclaimers

BioIntelScan surfaces publicly available enforcement and regulatory information and produces analytical output, including verdicts under the four-prong test of 21 CFR 1271.10(a), risk scores, suggested rewrites, and citations to enforcement actions and CFR provisions.

This output is not legal advice. No attorney-client relationship is formed by your use of the Service. You should confirm any compliance decision with qualified regulatory counsel.

BioIntelScan is intended for use by clinics, physicians, agencies, and investors evaluating regulatory risk. Nothing in the Service is medical advice or a recommendation to use, prescribe, or refrain from any therapy, product, or procedure. Patients and consumers should consult licensed healthcare providers for medical decisions.

The Four-Prong Scanner and Claim Clearance features evaluate text against publicly available regulatory frameworks using a combination of rule-based logic and AI models. AI-generated outputs can be inaccurate, incomplete, or out of date.

Scores, verdicts (pass / flag / fail), and precedent citations are analytical estimates and are not determinations by FDA, FTC, OPDP, SEC, CBER, DOJ, any state attorney general, or any other regulatory body. A “pass” verdict does not guarantee compliance; a “fail” verdict does not guarantee enforcement. Always confirm with counsel before publishing any claim.

The enforcement feed aggregates publicly available actions from regulatory agencies, courts, and reputable industry sources. We make commercially reasonable efforts to keep the feed accurate and current, but we do not guarantee completeness or freshness. Always verify against the original primary source before relying on a specific item for a compliance, business, or investment decision.

The Enforcement Risk Score and risk tier badges (critical / high / elevated / moderate / low) are analytical estimates derived from public enforcement signals. Methodology is described on the Methodology page.

Scores are not predictions of agency action against any company. They are not credit ratings, investment recommendations, or solicitations to buy or sell any security. Companies named in the feed have not been adjudicated as having violated any law except where an action explicitly says so on its face.

Deal-flow signals (M&A, IND filings, fundings, restructurings) and other intelligence signals are sourced from public filings and reputable industry reporting. They are provided for situational awareness and are not investment advice. Investors should perform independent due diligence and consult licensed financial advisors.

Some content (such as analysis of guidance shifts or projected enforcement trends) constitutes forward-looking statements. Actual outcomes may differ materially. Forward-looking statements are based on current information and assumptions and are not guarantees of future outcomes.

The Service and its output are provided “as is” and “as available” without warranties of any kind. See our Terms of Service, Sections 9 and 10, for complete disclaimer and limitation of liability language.

Company and product names mentioned in the enforcement feed and risk board appear for informational purposes only. All trademarks are the property of their respective owners. Inclusion in the feed is not an endorsement, partnership, or assertion of legal violation beyond what the underlying public action says on its face.

If you believe a specific item in the enforcement feed or risk board is inaccurate or warrants update, please email info@biointelscan.com with the company, item, and supporting documentation. We aim to review correction requests within five business days.

BioRegenEx Medical Technology · Texas, USA