#Pediatric Care #Denmark #Copenhagen #Hedia #Diabetes Assistant

Hedia Expands Diabetes Care to Pediatric Patients

In a significant advancement for diabetes management, Hedia, a Danish digital therapy company, has recently secured regulatory approval to extend its digital care solutions to pediatric patients. This achievement marks a landmark moment for the company and those affected by diabetes type 1 in younger populations.

Major Regulatory Milestone

Hedia successfully obtained the official certification under the Medical Devices Regulation (MDR), enabling the company to lift its age restriction of 18 years. This change permits parents, guardians, and caregivers to utilize the Hedia Diabetes Assistant for children under the age of 18. Furthermore, it facilitates direct usage for young patients themselves, reflecting Hedia’s commitment to inclusive healthcare solutions.

Enhanced Collaborative Care

The approval brings a new dimension of collaborative care for families managing diabetes type 1 in children. It allows for enhanced connectivity and integration of the Hedia Diabetes Assistant into both its standalone application and partner health platforms. This streamlined approach ensures continuous clinical workflow, vital for the management of diabetes in young patients.

Flexible Insulin Treatment Regimens

The regulatory certification empowers Hedia to establish flexible insulin treatment regimens tailored for pediatric patients. With more varied treatment parameters, caregivers can adjust doses more effectively based on individual needs. This adaptability is crucial in the pediatric setting, where diabetes management must be responsive to rapidly changing conditions.

Moreover, Hedia’s technology supports advanced data functionalities. This ensures seamless integration between Continuous Glucose Monitors (CGMs), connected pens, smartwatch devices, and mobile health platforms, providing comprehensive data that helps families and healthcare providers make informed decisions.

CEO's Vision

Rasmus Kofoed, CEO of Hedia, expressed his enthusiasm regarding the new regulatory approval, stating:

“This substantial regulatory authorization allows us to broaden our reach to pediatric clinics and specialized teams managing young patients. Managing diabetes in children necessitates precision, flexibility, and trust. By lifting the age restriction and expanding our treatment options, we can now create necessary links that connect clinics directly with families at home.”

Hedia aims to simplify data accessibility for healthcare professionals, caregivers, and patients alike, ultimately making daily management of diabetes easier, safer, and more interconnected.

Bridging the Gap in Diabetes Care

By bridging the gap between home care, device data, and clinical follow-up, Hedia is poised to transform daily diabetes management for families, promoting better glycemic control. The development and rollout of these features are set to commence shortly, marking a proactive approach to pediatrics in diabetes management.

About Hedia

Founded in 2016, Hedia develops digital therapeutic solutions aimed at aiding adults, children, and families dealing with insulin-dependent diabetes in managing their insulin treatment. The Hedia Diabetes Assistant calculates insulin doses using blood glucose data from CGMs, blood glucose meters (BGMs), and connected pens. It also includes a food database for carbohydrate counting and promotes physical activity support. Hedia collaborates with healthcare professionals, clinical teams, and partners in the digital health sector to enhance diabetes management through data-driven, connected care solutions.

For more information, visit Hedia's website.