Qure.ai's Aira has received Class IIb CE certification under the EU Medical Device Regulation for its clinical decision support system. Aira is designed for frontline primary care in emerging economies and is the first AI-powered CDSS to combine documentation, workflow automation, and analysis of patient EHR data with clinical decision-making under a single CE mark. The certification comes a year after Aira's launch and extends Qure.ai's decade of experience in regulated medical AI. Aira was launched at the World Health Assembly in 2025 to address workforce shortages, inconsistent adherence to clinical guidelines, and administrative burden in primary care.
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