European neonatal and pediatric intensive care stands at a crossroads. Rising acuity, increasing complexity, and persistent staff shortages are placing pressure on organizations that are already operating near or beyond safe occupancy levels. At the same time, EU's own strategic reports continue to highlight structural underinvestment in pediatrics and the limited availability of integrated digital tools that support both care and research.
Against this backdrop, our CE-MDR certification for Neolook’s professional clinical solution marks a significant milestone. It represents the completion of a unified, medical-grade platform designed for the realities of neonatal and pediatric care. A platform that combines family engagement, clinical situational awareness, research capability, and AI-driven innovation within a single architecture.
Today, this platform becomes available across the European Union and in all regions aligning with the Medical Device Regulation. For hospitals, networks, and policymakers, this moment offers a concrete step toward more equitable and efficient care.
Decision makers across Europe are confronted with a dual challenge. The number of newborns and children requiring complex intensive care continues to rise, while the availability of specialized nursing staff continues to decline. This structural imbalance threatens accessibility, quality, and continuity of care. Moreover, pediatric innovations often struggle to reach scale. Research groups work in isolation. Clinical insights remain local. Data streams are fragmented. Promising ideas take years to translate into practice.
Our CE-MDR milestone addresses these systemic issues directly. By certifying the final component of our platform, we now provide health systems with:
All running on the same secure, compliant, operational backbone.
This creates a digitally enabled infrastructure that supports day-to-day care, strengthens staff, empowers parents, and accelerates research - all without introducing additional operational burden.
The strength of the platform lies in its integration.
For policy makers and funders, this offers a pathway to scale innovations faster, with reproducibility and regulatory compliance built in from the start.
To ensure accessibility across all European healthcare settings, we designed the platform for flexible deployment:
Every model uses the same architecture, the same medical-grade components, and the same security standards (ISO 27001, NEN 7510, MDR). This allows hospitals to start small—sometimes with only a few beds—and grow into multi-department, multi-site, or network-wide deployments without architectural rework.
The system’s Doris architecture enables continuous updates, modular maintenance, and safe component replacement without downtime. In practice, hospitals gain a digital system that can evolve while care continues uninterrupted.
The completion of the CE-MDR certification enables something that has been difficult to achieve in pediatric and neonatal care: shared innovation. Research groups, hospitals, and clinical networks can now work within a common environment, using comparable data, workflows, and quality standards.
When one hospital develops or validates an algorithm—whether for cry detection, movement analysis, early warning signals, or other biomarkers—it can be evaluated across the network. Cohorts can be combined. Evidence can be strengthened. And once a model is proven, it can be deployed on the same platform that generated the evidence.
This creates a scalable innovation cycle that benefits the entire health system, not only the institution that developed the initial idea. It also allows policymakers and funders to support large-scale pediatric innovation with far greater confidence in reproducibility, clinical value, and operational feasibility.
Beyond clinical and research functions, the platform provides management teams with tangible operational advantages:
This means the system becomes part of the hospital’s accountability cycle, supporting safer operations, data-driven improvement, and continuous evaluation.
For national networks, the platform provides a consistent dataset that enables benchmarking, coordinated research, and shared learning, all while respecting data governance frameworks and hospital autonomy.
The completion of this platform also supports a broader policy objective: ensuring that every child receives high-quality care regardless of geography. A cloud-compatible, MDR-certified, multilingual platform lowers barriers for smaller hospitals, regional centers, and cross-border collaborations.
By integrating families, clinicians, and researchers into one environment, the platform supports a more equitable distribution of knowledge, oversight, and early detection capabilities. It ensures that innovation does not remain locked in large academic centers but becomes accessible across the entire pediatric ecosystem.
The CE-MDR certification of the professional solution is more than a product release. It represents the moment the full Neolook platform becomes available for structured adoption across Europe. For hospital boards, clinical leaders, and policy makers, it offers a realistic, scalable, and compliant approach to strengthening pediatric care at a time when structural pressures demand long-term solutions.
We believe this milestone marks the beginning of a new chapter for neonatal and pediatric innovation—one where families, clinicians, and researchers work in concert, supported by secure, medical-grade infrastructure.
If your organization is exploring options for:
Want to learn more? We would welcome a conversation.
We offer exploratory discussions, demonstrations, and joint discovery sessions with clinical, operational, and research stakeholders.
The platform is now fully certified, available, and ready to support hospitals and networks across Europe. We invite you to learn more and explore what is possible together.