Cardiolaxy (version 2.0.0) is indicated for the monitoring of heart failure patients. It allows an analysis of the overall evolution of biomedical dynamics to prevent cardiac decompensation.
Cardiolaxy is a Class IIa Medical Device bearing the CE mark according to the regulations.
For support in using the service, contact us by e-mail: support@cardiolaxy.care
Cardiolaxyis a medical software package for remote monitoring and diagnostic assistance allowing the remote therapeutic management of heart failure patients.
Cardiolaxy is indicated for monitoring of heart failure patients and assists with the early detection of cardiac decompensation.
Cardiolaxy also allows therapeutic education and remote patient support.
It is a class IIa medical device bearing the CE mark and is designed according to ISO 13 485 certified procedures.
Cardiolaxy results in improved patient care and reduced hospitalisation
Cardiolaxy provides reliable and secure assistance to caregivers in managing their patients remotely thanks to three main features:
Patients are sent a weekly questionnaire by SMS to report their symptoms in a few minutes.
The questionnaire can also be received by e-mail.
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The data is analysed and if any anomalies are detected, an alert is sent by e-mail.
The care team can access a clear table at any time to understand the patient’s health status and how it changed over the last few weeks.
This allows the care to be adapted if necessary.
Patients have access to therapeutic education content adapted to their reported symptoms and pathology, to help them better understand what they should do and can do on a daily basis.
This reduces the burden on care teams and allows them to focus on patients who require more comprehensive support.
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1. Biannic C., Coutance G., Calus J., et al. Educational home follow-up by telemedicine in cases of cardiac insufficiency. Randomised, multicentric study from the Basse-Normandie region. Preliminary results. Eur Telemed Res. 2012;1:40-48
2. Galinier M, Roubille F, Berdague P, et al. Telemonitoring versus standard care in heart failure: a randomised multicentre trial. Eur J Heart Fail. 2020;22(6):985-994. doi:10.1002/ejhf.1906
3.Ong MK, Romano PS, Edgington S, et al. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial [published correction appears in JAMA Intern Med. 2016 Apr;176(4):568] [published correction appears in JAMA Intern Med. 2016 Jun 1;176(6):871]. JAMA Intern Med. 2016;176(3):310-318. doi:10.1001/jamainternmed.2015.7712
4.Olivari Z, Giacomelli S, Gubian L, et al. The effectiveness of remote monitoring of elderly patients after hospitalization for heart failure: The renewing health European project [published correction appears in Int J Cardiol. 2018 Apr 21;:]. Int J Cardiol. 2018;257:137-142. doi:10.1016/j.ijcard.2017.10.099
Cardiolaxy meets the most stringent regulatory requirements in terms of quality and safety
Cardiolaxy is a Class IIa Medical Device declared to the ANSM,
bearing the CE mark
We’re certified by GMED as meeting the requirements of the international standard ISO 13485.
We’re aligned with the requirements of PGSSI-S / ISO 27001: the safety of patients and the security of their data is ensured.
We comply with the GDPR requirements on data processing and the provision of good information to our users.
Simply send us an e-mail and our team will contact you as soon as possible:
contact@betterise-healthtech.com
Name: Cardiolaxy
Indication Cardiolaxy (version 2.0.0) is indicated for the monitoring of heart failure patients. It allows an analysis of the overall evolution of biomedical dynamics to prevent cardiac decompensation.
Date of last modification: V2.0.0, 4.11.2020
Regulatory information
Cardiolaxy is a clinical decision support software used for the follow-up of patients with heart failure.
Cardiolaxy allows the analysis of the global evolution of bio-medical dynamics in order to detect early cardiac decompensation.
Cardiolaxy is a Medical Device bearing the CE mark. In accordance with rule 10 of Annex IX of Directive 93/42/EEC, Oncolaxy is classified as a Class IIa device.
Cardiolaxy is manufactured by Betterise Technologies, 24 Avenue Victor Hugo 64200 Biarritz FRANCE, under certified procedures that comply with the requirements of the international standard ISO 13485:2016.
This medical device is a regulated health product that bears, under this regulation, the CE marking
All users are invited to read, before any first use, the instructions for use provided.
For any question or request for assistance, please contact the support by email : support@cardiolaxy.care
