Question 1

Is GraftAI a medical device?

Accepted Answer

Not currently. Software that outputs a graft count used to plan a procedure may fall within the EU Medical Device Regulation, and we are being assessed against the MDR classification rules. GraftAI is not CE-marked as a medical device today and is not marketed as one. The outcome of that assessment will be published here when it concludes.

Question 2

How accurate is the graft count?

Accepted Answer

We have not yet validated it against counts recorded in theatre, so we do not publish an accuracy figure. That validation is the first milestone of the current funding round. When we have it, the number and the method will both be published — including if it is worse than we expect.

Question 3

Where is patient data stored, and who can see it?

Accepted Answer

In the EU. Scalp photographs are health data under GDPR Article 9 and are stored against a consented patient record with a lawful basis recorded at capture. Access is scoped to the clinic and to the role, so a receptionist cannot open an operative photo set.

Question 4

Can it run on our own servers?

Accepted Answer

Yes. For clinics whose procurement or jurisdiction will not allow patient imagery to leave their own infrastructure, the platform ships as an on-premise installation rather than as a hosted service.

Question 5

Do we need special cameras or equipment?

Accepted Answer

No. The analysis runs on calibrated photographs taken with equipment a clinic already has. What matters is that the shots are standardised — the same angles each time — which is what the capture flow enforces.

Question 6

How is it priced?

Accepted Answer

A flat per-clinic subscription with unlimited patient profiles and unlimited report generation, rather than per-seat or per-report metering — a clinic should never be choosing whether a patient is worth a report. Patients pay nothing. On-premise installation and multi-site licences are quoted separately. Current figures are shared on request.

Question 7

What happens to our data if we stop using GraftAI?

Accepted Answer

It is yours. Patient records, photographs and generated reports export in full, and the clinic remains the data controller throughout. There is no lock-in mechanism in the contract or in the product.

Question 8

How long does it take to get running?

Accepted Answer

The platform is web-based with nothing to install, so a clinic can be creating records the same day. Migrating an existing back-catalogue of patients is the part that takes planning, and we scope it per clinic.

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