#Denmark #Copenhagen #digital health #diabetes #Hedia

Hedia Expands Digital Diabetes Care to Pediatric Patients

In a significant regulatory achievement, Hedia, a Danish digital therapeutics company, has announced its official certification under the Medical Device Regulation (MDR) to extend its digital diabetes support offerings to pediatric patients. This certification allows Hedia to eliminate its previously imposed age restriction of 18+, enabling parents, guardians, and caregivers to utilize the Hedia Diabetes Assistant for children and adolescents under 18, in addition to its use by adults.

This milestone represents a promising development for families managing Type 1 diabetes in children, facilitating easier cooperative care. With the recent updates, pediatric support will be available both in Hedia's standalone app and integrated within the digital health platforms of their partners, ensuring continuity of clinical workflows.

Furthermore, the approval introduces flexible insulin therapies that feature broader treatment parameters tailored specifically for young patients. The enhanced data functionalities will enable seamless connectivity between continuous glucose monitors (CGMs), smart pens, smartwatches, and mobile health platforms, ultimately supporting better diabetes management.

Rasmus Kofoed, CEO of Hedia, expressed the company’s commitment to pediatric care, stating: “Achieving this milestone in our regulatory pathway enables us to expand our focus on pediatric clinics and the dedicated teams caring for young patients. Treating diabetes in children requires precision, flexibility, and trust. By removing the age restriction and obtaining approval for more comprehensive support through treatment plans and devices, we can build necessary connections to bridge clinics directly with families at home. Our objective is to optimize access to data for healthcare professionals, caregivers, and patients, making daily care simpler, safer, and more connected.”

As Hedia bridges the gap between home care, device data, and clinical oversight, it will be able to optimize daily diabetes care for families while also supporting better blood sugar control. The development and implementation of these features are set to commence shortly.

About Hedia

Founded in 2016, Hedia develops digital therapeutic solutions designed to assist adults, children, and families in managing insulin-dependent diabetes. The Hedia Diabetes Assistant aids in calculating insulin dosage based on blood sugar readings from connected CGMs, blood glucose meters (BGMs), and smart pens, facilitates carbohydrate counting through an integrated food database, and tracks physical activity. Hedia collaborates with healthcare providers, clinical teams, and digital health partners to enhance diabetes care through connected, data-driven approaches. For more information, visit www.hedia.com.