Safety & compliance

CKD Twin and related Thinking Labs materials help patients and clinicians explore cardio-kidney-metabolic concepts together. They are not intended to diagnose, treat, cure, or prevent disease on their own. Licensed clinicians retain full responsibility for care.

We are not claiming clearance today. Longer term, if product features move beyond educational demonstration, Thinking Labs expects to pursue an appropriate U.S. regulatory pathway—which may include early programs such as FDA’s TEMPO-related efforts for digital health innovation, followed by the clearance or authorization route that fits the final intended use. That work is future-facing. Nothing on this site implies present FDA clearance.

When clinics or health systems enroll for workflows that involve protected health information, Thinking Labs will put Business Associate Agreements (BAAs) and appropriate safeguards in place before those deployments. Public demos and marketing pages are not clinic enrollment.