Qure.ai's Clinical Decision Support System Aira Among World's First to Win Class IIb CE Certification

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.

MUMBAI, India and NEW YORK, Sept. 18, 2026 /PRNewswire/ -- Qure.ai, 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.

In its first year, Aira has scaled to ten live pilot sites reaching thousands of patients and care seekers across wide-ranging last-mile and urban contexts in Nigeria, Kenya, Mozambique, Solomon Islands and Bangladesh. In Nigeria, it supports ART-center (Anti-Retroviral Therapy) health workers with structured data capture and guideline-based decision support, delivered with the Catholic Caritas Foundation of Nigeria in Enugu and Ebonyi, and the Adamawa State HIV/AIDS and STI Control Program.

In Kenya, Aira is deployed with local implementation partners and Ministry of Health departments. In Mozambique, it is integrated into AlôVida, the national platform run by the Ministry of Health (MISAU), with VillageReach as implementing partner and Qure.ai providing the technology, supporting pandemic preparedness through a Gates Foundation initiative. In the Solomon Islands, Aira has digitized paper-based health reporting in support of WHO's Western Pacific Regional Office national reporting work. In Bangladesh, it is being deployed with the support of Endless Health.

In a Kenya outreach program, Aira cut time spent on protocol-driven documentation by 32% while ensuring a 98% completion rate in documentation tasks. Within primary HIV care facilities in Nigeria, the clinical-to-administrative time ratio improved by 67% in favor of patient-facing time, alongside a 23% reduction in administrative time.

Aira also supports continuous patient care between visits. In Nigeria, automated calls in Hausa and English remind patients about upcoming appointments and reconnect with patients who have missed scheduled care while also helping ensure consistent adherence to clinical protocols across teams.

Qure.ai's broader AI portfolio is deployed across 105+ countries, with 26+ FDA-cleared findings and CE marking for 60+ indications. The company is now working with ministries of health and institutional funders on population-scale deployments of Aira over existing national systems, with the aim of building a larger evidence base for AI-supported care and patient outcomes.

Qure.ai believes this is the beginning of a broader shift: AI that doesn't just support diagnosis but strengthens the entire primary care system around it, turning every health worker interaction into an opportunity for guideline-driven, data-backed care. At population scale, this is how the global health community closes the primary care gap for the billions still underserved.

To know more about Aira: https://www.qure.ai/aira

About Qure.ai

Qure.ai is a global AI company innovating diagnostic solutions in healthcare for early detection and care management. Qure's solutions power early diagnosis in lung cancer, neurology and infectious disease to support clinicians and propel developments in the pharmaceutical and medical device industries. The company empowers healthcare workers or health systems by helping to identify conditions fast, prioritize treatment planning and ultimately improve quality of patient life. Qure.ai has deployments in over 107 countries, with regional offices in New York, London and Mumbai. It is a TIME100 Most Influential Company 2025.