As Europe navigates an increasingly competitive global AI healthcare landscape, Spanish health tech startup Tucuvi is making headlines by becoming the first voice-based AI solution in Europe to gain Class IIb medical device certification.
Tucuvi is a Spanish health tech startup which developed a medical voice assistant, LOLA, that enables remote patient monitoring through conversational AI. Tucuvi’s breakthrough, backed by ISO 13485 certification and tailored support from EIT Health programmes, comes at a critical moment. A new AI skills report jointly released by EIT Health and EIT Digital highlights the urgent need for upskilling across Europe to remain competitive on the global stage in AI healthcare applications. The report calls for a coordinated European strategy to build human capital in AI and digital health.
Tucuvi’s rapid progress also exemplifies what the AI skills report stresses: combining deep sector expertise and interdisciplinary soft skills as a key differentiator for European AI companies. The company’s trajectory underscores the strategic role EIT Health plays in nurturing startups from ideation to internationalisation, with accelerator programmes offering access to mentors, regulators, and pharma partners across Europe. Impactful innovation happens when education, research, and business are brought together in applied, practical ways, and enabled to exchange skills fluidly across disciplines. The most impactful advances in AI and healthcare stem from this convergence of technical, scientific, and managerial capabilities.
A European wave of AI-driven health innovation
Tucuvi’s success is part of a pan-European wave of AI-enabled health innovation emerging from the EIT Health ecosystem. Their solution supports decision making when delivering diagnoses with reliable and safe data. Across Europe, start-ups are leveraging artificial intelligence to transform diagnostics, treatment, and patient care, with many achieving regulatory milestones and global commercial traction thanks to EIT Health’s multi-stage support model.
BrainTrip, based in Malta, has developed the NeuroAI platform, which interprets EEG data to deliver fast, non-invasive cognitive assessments. Its flagship tool, the BrainTrip Dementia Index (CogniScore), is CE‑marked and achieves roughly 95% diagnostic accuracy within a 30-minute test, compared to traditional neuropsychological evaluations that last over an hour. With over 2,000 tests performed, BrainTrip is scaling in Europe with EIT Health support in regulatory strategy, mentoring, and clinical integration.
These start-ups reflect a growing pan-European innovation movement, grounded in regulatory readiness, cross-sector integration, and patient-first design.
Their momentum aligns with key insights from the EIT Health and EIT Digital AI Skills and Occupations in the European startups ecosystem, which calls for a unified European strategy to combine technical excellence, ethical standards, and practical implementation. These start-ups show that such a strategy is not only possible – it’s already underway.
