Overview
- Hedia secured Medical Device Regulation (MDR) certification to expand its Hedia Diabetes Assistant to patients under 18.
- The update enables parents, caregivers, and healthcare teams to support pediatric diabetes management through the app and partner digital health platforms.
- The certification also expands insulin regimen options and connectivity with CGMs, smart pens, smartwatches, and mobile health platforms.
The News
Danish digital therapeutics company Hedia has received MDR certification allowing its Hedia Diabetes Assistant to support children and adolescents with diabetes, removing its previous 18+ age restriction. The pediatric offering will be available through the standalone Hedia app and integrated partner digital health platforms.
The certification also enables broader insulin regimen settings that can be tailored to younger patients, while expanding data connectivity across continuous glucose monitors, smart pens, smartwatches, and other mobile health platforms. Hedia plans to begin development and rollout of the expanded features shortly.
Industry Perspective
Managing diabetes in children requires coordination between patients, caregivers, and clinical teams, with much of the day-to-day care taking place at home. Connecting device data and treatment information across these settings can help create greater continuity between home-based management and clinical oversight.
Strategic Impact
The certification expands Hedia’s addressable patient population into pediatric diabetes care while strengthening its role as a connected digital support tool. Broader device integration and flexible treatment settings could also help Hedia integrate more closely with pediatric clinics, families, and partner digital health platforms.
Source: PRnewswire
