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 |
| v3(240305) | 3.6 | 05-03-2024 | Minor changes (various improvements: alerts, dynamic lists, coaching view, profile, study theming)
|
No |
|
v3(240404)
|
3.7 | 04-04-2024 | Minor changes (subject notifications improvements, nutrition widget improvements, portal globalization, smart profiler) | No |
