Qure.ai gains EU Class IIb certification for Aira AI clinical support platform

USA—Qure.ai, a global developer of artificial intelligence (AI) solutions for healthcare, has announced that Aira, its clinical decision support system (CDSS), has received Class IIb CE certification under the European Union Medical Device Regulation (MDR).

The certification comes a year after Aira was launched and expands Qure.ai’s experience in regulated medical AI beyond tuberculosis, lung cancer and other noncommunicable diseases into clinical decision support.

Supporting primary healthcare workers

Launched at the World Health Assembly in 2025, Aira addresses three challenges facing primary healthcare: staff shortages, inconsistent use of clinical guidelines and the administrative workload that limits the time health workers spend with patients.

The platform works alongside existing health systems as an AI layer.

It converts consultations and paper records into digital care records, provides health workers with patient histories and recommendations based on national guidelines, and helps maintain contact with patients between visits.

Aira also supports local languages, existing digital devices and settings with unreliable internet connectivity.

This approach allows health workers to incorporate digital tools into routine care without adding separate administrative tasks.

“The quality of primary care a person receives should not be decided by their postcode,” said Prashant Warier, cofounder and chief executive officer of Qure.ai.

He added that health workers often have to divide their attention between patients, paperwork, clinical guidance, and appointment follow-up.

According to Warier, Aira is designed to handle some of these tasks while providing clinical decision support within a regulated framework.

Deployment across five countries

During its first year, Aira has expanded to 10 pilot sites serving thousands of patients and care seekers in Nigeria, Kenya, Mozambique, the Solomon Islands, and Bangladesh.

In Nigeria, the platform supports health workers at antiretroviral therapy centres by providing structured data capture and guideline-based decision support.

Qure.ai is implementing the programme with the Catholic Caritas Foundation of Nigeria in Enugu and Ebonyi and the Adamawa State HIV/AIDS and STI Control Program.

In Kenya, Aira operates with local implementation partners and Ministry of Health departments.

In Mozambique, it is integrated into AlôVida, a national health platform operated by the Ministry of Health, with VillageReach as the implementation partner and Qure.ai providing the technology.

The platform has also digitized paper-based health reporting in the Solomon Islands in support of national reporting work with the World Health Organization Western Pacific Regional Office.

In Bangladesh, Qure.ai is deploying Aira with support from Endless Health.

Measuring administrative efficiency

Qure.ai reported that Aira reduced time spent on protocol driven documentation by 32% in a Kenyan outreach programme while achieving a 98% documentation completion rate.

In Nigerian primary HIV care facilities, the company reported a 67% improvement in the clinical to administrative time ratio, alongside a 23% reduction in administrative time.

Aira also uses automated calls in Hausa and English to remind patients about appointments and reconnect with those who miss scheduled visits.

Qure.ai said its wider AI portfolio is deployed in more than 105 countries, with more than 26 FDA-cleared findings and CE marking for more than 60 indications.

The company is now working with health ministries and institutional funders to expand Aira across national health systems.

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