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 | Intended purpose | 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. | 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. | AFMPS (BE) |
| 01-03-2025 | v4 (MDR)
54199801789HLTv4GY |
Class lla | HEALTHENTIA is a software intended for: a) the collection and transmission of physiological data including heart rate, blood pressure, oxygen saturation, and weight directly to care providers via automated electronic means in combination with validated IoT devices; b) the visualization (subjects-based dashboards) and the mathematical treatment of data (trends analysis, alerts) related to the monitored chronic disease subject’s physiological parameters; c) the transmission of patient’s outcomes and outcome scores related to patient’s health status, health-affecting factors, health-related quality of life, disease knowledge and adherence to treatment through validated questionnaires; d) the user (subject/patient) interaction with a conversational virtual coach for informative and motivational purposes, in order to support subject telemonitoring, decision making and virtual coaching.
Clinical indications: Telemonitoring of chronic disease patients (such as heart failure, cancer, COPD, etc.) Patients target group: Chronic disease patients taking part of clinical investigation or a medical treatment Intended users: Telemonitored patients and their healthcare professionals |
Kiwa Dare Services |
