FDA Wants a New Kind of Proof for GenAI Medical Devices
The FDA is exploring competency testing, a two-axis risk framework and postmarket monitoring for GenAI-enabled medical devices.
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The FDA is exploring competency testing, a two-axis risk framework and postmarket monitoring for GenAI-enabled medical devices.
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Pasal 50 Undang-Undang AI Uni Eropa berlaku sejak 2 Agustus 2026 dan menjangkau penyedia di luar Eropa bila keluaran sistemnya digunakan di Uni Eropa.
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O Artigo 50 da Lei de IA da UE vale desde 2 de agosto de 2026 e alcança fornecedores fora da Europa quando a saída do sistema é usada na União.
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Article 50 of the EU AI Act applies from 2 August 2026, and it reaches providers outside Europe when their AI output is used in the Union.
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