Galet is not a medical device.
We've been careful about every line that separates "home companion" from "software as a medical device." This page says in plain language what those lines are, and why we think Galet sits firmly on the home-companion side of them.
What SaMD means.
"Software as a Medical Device" (SaMD) is a regulatory category used by Health Canada, the US FDA, and most global regulators to cover software that — on its own — is intended to diagnose, treat, prevent, or mitigate a disease or medical condition. SaMD carries specific regulatory requirements around clinical evidence, quality management, and post-market surveillance.
Galet is designed to sit outside this category, and we take deliberate product decisions to keep it there.
What Galet does.
- Home logging. A plain record of meals, hydration, and digestion that your family chooses to keep.
- Pattern surfacing. Descriptive summaries of what you've logged — which nutrients show up, how often a digestion pattern repeats, how a stretch went.
- Parent-led planning. Food Stretching is a planner for your own trying. Food Chains is an AI-assisted suggestion engine that you review before you use.
- Clinician-ready export. A PDF summary you can choose to share with your care team.
What Galet does not do.
- Does not diagnose any condition — including (but not limited to) ARFID, autism, ADHD, constipation, IBS, food allergies, or failure to thrive.
- Does not predict health outcomes or risk.
- Does not prescribe a diet, treatment, or therapy.
- Does not interpret labs, images, or any clinical test.
- Does not replicate or substitute for a clinical feeding-therapy protocol.
- Does not calculate a clinical score (e.g., no ARFID severity score, no nutritional-deficiency risk score).
- Does not claim that using Galet will cause, improve, reverse, or prevent any medical condition.
Bristol Stool Scale — a note.
Galet uses a pediatric-adapted version of the Bristol Stool Scale as a descriptive tool, the same way a feeding clinic or GI office might. Describing a stool type is not a diagnosis. Galet does not interpret Bristol patterns as "normal," "abnormal," "constipation," or "diarrhea" — those are clinical judgments that belong with your child's clinician.
Nutritional reference ranges — a note.
The targets Galet shows for fibre, iron, calcium, protein, and hydration are general pediatric reference ranges, not prescribed goals. Many healthy children live outside these ranges, especially during periods of restricted safe-food lists. Galet's numbers are for your awareness — and for a clinician conversation if they concern you.
The AI in Food Chains — a note.
The AI-assisted suggestions in Food Chains are not clinical recommendations. They are creative proposals for small sensory bridges, generated by a language model with a narrow, clinician-reviewed prompt. They are not evaluated for any medical claim. You review every step before you try it, and you can edit or discard freely. See our Food Chains page for the full AI disclosure.
If your child's situation is medically urgent.
Ongoing review.
Our product, marketing, and clinical content is reviewed with our paediatric GI CMO to keep these lines clean. We're not perfect; if you see a claim on our website or in our app that crosses into medical-device territory, please tell us. We'll fix it.
Contact: maxime@galet.app