The Medavo application advertises itself as an “Offline Medical AI Scribe” and is designed to transcribe medical conversations. This functionality qualifies as a medical device in every jurisdiction — EU, USA, Middle East, Asia — because it produces documentation that influences clinical decision‑making. The definition of a medical device is global and not region‑dependent: IMDRF, WHO, EU MDR, and the FDA all classify software that generates clinical documentation as a medical device.
Medavo holds no CE certification, no FDA 510(k) clearance, and no internationally recognized medical device authorization. Therefore, the product is considered an “unauthorized medical device” in every country.
The Apple App Store is globally responsible for medical device compliance, regardless of whether the user is located in the EU, the USA, or Dubai. Platform responsibility is not region‑limited.
Google’s own Health AI Developer Foundations documentation explicitly states that MedGemma/MedASR is “NOT an approved medical device,” and that clinical use of Google models is prohibited worldwide. This prohibition is global and not restricted to the EU or the USA.
Despite this, two Google employees (posting with Google badges and official Google profiles) openly congratulated the use of MedASR in a real clinical workflow and the clinical launch of the Medavo application. This is not user‑generated content — it is Google‑generated content that directly endorses the clinical use of a non‑certified medical device.
This constitutes a violation of Google’s own global policy and amounts to platform‑level clinical endorsement, regardless of whether the user is in Dubai or anywhere else. Public validation of clinical workflows by Google employees creates worldwide legal exposure.
If Medavo makes an error (e.g., hallucinating a drug name or symptom) and a patient is harmed, the liability chain is clear:
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Clinicpoints Ltd. — the manufacturer of the software
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Apple — the platform that allowed distribution of a non‑certified medical AI
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Google — the platform whose official employees publicly endorsed its clinical use
This is not region‑dependent, not Dubai‑dependent, and not location‑dependent. It is a global medical device compliance issue.