The following table lists the major versions of Healthentia, including v1, which was not a Medical Device:

Date Version

Basic UDI-DI

Medical Device Class Intendent purpose DoC Competent authority / NB



v1 (MDD) not a MD - - -
28-04-2020 v2 (MDD)



Class I Software intended for

monitoring of non-vital parameters to support decision making during clinical trials.

25-05-2021 v3 (MDD)


Class I Software intended for

monitoring of non-vital parameters to support decision making and virtual coaching of patients during clinical trials or under a medical or wellbeing treatment context.




The following table presents the description of changes between software versions, including minor updates:

SW Version Healthentia SW version  SW release date Description New medical function
v2(200423) 2.7 23/04/2020 Class I - submitted to AFMPS (Belgium) n/a
v2(201105) 2.8  5/11/2020 Minor changes (eConsent) No
v3(210525)   3 25/05/2021 Updated submission to AFMPS (mobile app widgets) Yes
v3(211018) 3.1 19/10/2021 Minor changes (software performance, new IoT devices) Yes
v3(220419) 3.2  19/04/2022 Minor changes (software performance, Terms/Privacy pop-up, messaging improvements, UI fixes) No
v3(221219) 3.3 19/12/2022 Minor changes (Data protection improvements, software performance) No
v3(230930) 3.4 30/09/2023 Minor changes (IoT device
validation, Glucose meter, software performance)
v3(240108) 3.5 08/01/2024 Minor changes  (registration flow refactor, medication adherence, time zone, subject notification improvements, weight goal, performance improvements) No
v3(240305) 3.6 05-03-2024 Minor changes (various improvements: alerts, dynamic lists, coaching view, profile, study theming)




3.7 04-04-2024 Minor changes (subject notifications improvements, nutrition widget improvements, portal globalization, smart profiler) No
v3(240513) 3.8 13-05-2024 Minor changes (diet nutrition widget refactoring, diet widget improvements, apple health sleep stages, several bug fixes) No