Qure.ai has received Class IIb CE certification under the European Union Medical Device Regulation for Aira, its artificial intelligence-powered clinical decision support system.
The certification extends Qure.ai’s regulated medical AI portfolio beyond its existing applications in tuberculosis, lung cancer and other non-communicable diseases into broader clinical decision support.
Aira was launched at the World Health Assembly in 2025 and is designed primarily for frontline primary care, particularly in healthcare systems facing workforce shortages and limited clinical resources.
The platform combines clinical documentation, workflow automation, analysis of patient electronic health record data and decision support within a single system.
Qure.ai said the platform was developed to address three persistent challenges in primary care: workforce shortages, inconsistent adherence to clinical guidelines and administrative workloads that reduce the amount of time healthcare workers can spend with patients.
By analysing existing patient information and supporting clinicians through routine workflows, Aira is intended to help healthcare workers make more consistent clinical decisions while reducing administrative burden.
The Class IIb classification under the EU MDR reflects the system’s role in supporting clinical decision-making rather than operating solely as an administrative or documentation tool.
The certification comes as healthcare organisations increasingly examine how generative and agentic AI can move beyond isolated applications and become embedded into clinical workflows.
For health systems in emerging markets, the opportunity is particularly significant where clinician availability remains limited and digital infrastructure is expanding.
Qure.ai is positioning Aira as part of a broader shift towards AI-enabled care orchestration, where diagnostic information, patient records and workflow tools can be combined to support clinicians throughout the care pathway.
The regulatory milestone also provides a pathway for broader deployment of Aira in markets recognising CE certification as Qure.ai continues expanding its clinical AI portfolio.
