Built for local languages, existing digital devices and unreliable connectivity, Aira makes digitization part of care delivery rather than an additional task for overstretched frontline workers.
Built for frontline primary care in emerging economies, Aira is the first AI-powered clinical decision support system (CDSS) to combine documentation, workflow automation and analysis of patient EHR data with clinical decision-making under a single CE mark.
Qure.ai (www.Qure.ai/aira), a global leader in AI-powered early diagnosis and care orchestration, today announced that Aira has received Class IIb CE certification under the EU Medical Device Regulation (MDR) for its clinical decision support system (CDSS). This milestone comes a year after Aira’s launch and extends Qure.ai’s decade of experience in regulated medical AI – spanning TB, lung cancer and other non-communicable diseases – to AI powered clinical decision support.
Launched at the World Health Assembly in 2025, Aira is built to address three persistent challenges in primary care: workforce shortages, inconsistent adherence to clinical guidelines, and the administrative burden that takes health workers away from patients. The platform integrates with existing health systems as an AI layer on top, turning consultations and paper records into a digital care trail, equipping health workers with patient history and national guideline-based recommendations, and maintaining patient contact between visits. Built for local languages, existing digital devices and unreliable connectivity, Aira makes digitization part of care delivery rather than an additional task for overstretched frontline workers.
By automating routine documentation and follow-up, and delivering current clinical guidance into everyday care, Aira helps stretched health workers maximize their time to deliver higher quality care. The ambition is to make consistent, connected primary care possible even where workforce capacity and digitization remain limited.
“The quality of primary care a person receives should not be decided by their postcode,” said Prashant Warier, Co-founder and CEO of Qure.ai. “But a health worker cannot give a patient their full attention while filling registers, searching for guidance and chasing missed appointments. We built Aira to take on that work. Class IIb certification is an important milestone because it validates our clinical decision support within one of the world’s most rigorous medical device regulatory frameworks. The bigger ambition is to put dependable clinical intelligence within reach of the people delivering care where resources are stretched furthest.”
Under the EU Medical Device Regulation, Class IIb classification reflects one of the EU’s highest levels of regulatory scrutiny for software supporting decisions where accuracy and reliability are critical to patient outcomes. Aira’s clinical decision support has been certified under this framework, giving health ministries, providers and funders an independently assessed foundation for evaluation and procurement, subject to applicable local rules.
Continue reading with Eandel
Subscribe to unlock the complete story and receive your subscriber benefits.
