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
 

17-12-2019

 

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

54199801789HLTv2GU

 

Class I Software intended for

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

Link AFMPS (BE)
25-05-2021 v3 (MDD)

54199801789HLTv3GW

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.

Link AFMPS (BE)

 

 

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)
 No
v3(240108)  3.5 08/01/2024 Minor changes  (registration flow refactor, medication adherence, time zone, subject notification improvements, weight goal, performance improvements)  No