Hedia Secures Regulatory Approval for Pediatric Diabetes Digital Care Expansion

Hedia, a digital therapy company based in Denmark, has made significant strides in diabetes management by obtaining a crucial regulatory milestone—official certification under the Medical Device Regulation (MDR). This approval will allow Hedia to broaden its digital diabetes support services to include pediatric patients, thereby lifting the age restriction of 18 years. This significant development not only enhances accessibility but also enables parents, guardians, and caregivers to utilize the Hedia Diabetes Assistant app for children and adolescents under 18 years of age, in addition to adult users.

In the world of Type 1 diabetes management for children, this approval represents a substantial improvement, paving the way for more streamlined and collaborative care. The updated certification facilitates pediatric support through both the independent Hedia app and integration with associated digital health platforms, ensuring continuity in clinical workflows. By incorporating pediatric care, Hedia aims to simplify the management process for families navigating the challenges of diabetes.

One of the key features of this new approval is the provision for flexible insulin regimens that can be tailored to accommodate the specific needs of young patients. This flexibility is crucial in ensuring that treatment is personalized, effective, and adaptive to the dynamic nature of child development and lifestyle.

Moreover, the certification will enhance data management capabilities, enabling seamless connectivity between Continuous Glucose Monitoring (CGM) systems, smart pens, smartwatches, and mobile health platforms. This interconnected ecosystem is designed to empower both caregivers and young patients, making daily management of diabetes less burdensome and more efficient.

Rasmus Kofoed, Hedia's CEO, expressed enthusiasm about this regulatory achievement, asserting, "Achieving this regulatory milestone allows us to expand our focus towards pediatric clinics and specialized teams that cater to young patients. Treating diabetes in children requires precision, flexibility, and trust. By removing the age restriction and gaining approval for a wider range of regimens and devices, we can establish the necessary connections to link clinics directly with families in their homes. Our goal is to streamline data access for healthcare professionals, caregivers, and patients, making daily treatment simpler, safer, and more connected."

Through this approach, Hedia is poised to bridge the gap between home care, device data, and clinical oversight, facilitating daily diabetes care for families, while also promoting better glycemic control. The development and rollout of these functionalities are expected to begin shortly, signaling a new era of accessible and responsive diabetes management for children and their families.

Founded in 2016, Hedia specializes in developing digital therapeutic solutions that assist adults, children, and families managing insulin-dependent diabetes. The Hedia Diabetes Assistant empowers users by calculating insulin dosages utilizing glucose data from CGM systems, blood glucose meters (BGM), and connected smart pens. It incorporates a comprehensive food database for carbohydrate counting and provides support for physical activity. Hedia collaborates closely with healthcare professionals, clinical teams, and partners in the digital health sector to enhance diabetes control through connected and data-driven care.

For more information, visit www.hedia.com.