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Project cooperationUpdated on 11 December 2025

Healthentia - a Class IIa MDR app for chronic disease patients

CEO at Healthentia

Brussels, Belgium

About

Healthentia is a Class IIa MDR-certified Software as a Medical Device designed for chronic disease patients and for conducting high-quality clinical studies. Deployed across 10+ countries, it combines validated Remote Patient Monitoring, rich patient-reported outcomes, and seamless integration with IoT devices to support real-world evidence generation at scale.

Beyond medical-grade data collection, Healthentia introduces one of the most advanced digital health innovation layers in Europe: Agentic AI–powered Behavioral Change Coaching and Generative AI modules that deliver hyper-personalized lifestyle support, improving engagement, adherence, and long-term outcomes.

The platform is built on a robust regulatory foundation, ensuring full conformity with MDR, ISO 13485, IEC 62304, and AI Act obligations. This makes Healthentia an ideal partner for R&D consortia seeking a clinically proven, technologically cutting-edge, and regulation-ready platform for trials, digital therapeutics, AI research, longitudinal studies, and large-scale population health interventions.

Topic

  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-02: Innovative interventions to prevent the harmful effects of using digital technologies on the mental health of children and young adults
  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-03: Advancing research on the prevention, diagnosis, and management of post-infection long-term conditions
  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-09: Multisectoral approach to tackle chronic non-communicable diseases: implementation research maximising collaboration and coordination with sectors and in settings beyond the healthcare system (GACD)
  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-11: Understanding of sex and/or gender-specific mechanisms of cardiovascular diseases: determinants, risk factors and pathways
  • DESTINATION 3: HORIZON-HLTH-2026-01-DISEASE-15: Scaling up innovation in cardiovascular health
  • DESTINATION 4: HORIZON-HLTH-2026-01-CARE-01: Public procurement of innovative solutions for improving citizens' access to healthcare through integrated or personalised approaches
  • DESTINATION 4: HORIZON-HLTH-2026-01-CARE-03: Identifying and addressing low-value care in health and care systems
  • DESTINATION 5: HORIZON-HLTH-2026-01-TOOL-06: Support to European Research Area (ERA) action on accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices
  • DESTINATION 5: HORIZON-HLTH-2026-01-TOOL-07: Establishing a European network of Centres of Excellence (CoEs) for Advanced Therapies Medicinal Products (ATMPs)
  • DESTINATION 6: HORIZON-HLTH-2026-01-IND-03: Regulatory science to support translational development of patient-centred health technologies

Type

  • Partner seeks Consortium/Coordinator

Organisation

Healthentia

Company (SME)

Brussels, Belgium

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