Aira now carries Class IIb certification under Europe’s Medical Device Regulation, the tier the bloc reserves for software whose advice can shape a patient’s treatment. The clearance belongs to Qure.ai and covers its decision support platform for primary care.
That classification sits among the EU’s highest tiers of regulatory scrutiny for clinical software. Aira launched at the World Health Assembly in 2025 and targets three chronic problems in primary care: workforce shortages, uneven guideline adherence and administrative load.
The system layers onto existing health systems, turning consultations and paper registers into a digital care trail. It automates routine documentation, surfaces current clinical guidance and handles follow-up.
Ten pilot sites went live in its first year, spread across Nigeria, Kenya, Mozambique, Solomon Islands and Bangladesh. A Kenyan outreach program reported a third less time on protocol-driven paperwork, with documentation tasks completed 98% of the time. The clearest shift came at Nigerian HIV clinics, where clinical time rose 67% against administrative time.
The wider Qure.ai catalogue is deployed in over 105 countries. It holds more than 26 FDA-cleared findings and CE marking across 60-plus indications. Ministries of health and institutional funders are the next target, with population-scale rollouts planned on national systems.
