1 Minute pour mon Cœur

By Newcard

1 Minute pour mon coeur is a standalone medical device software, intended to be used by healthcare professionals for medical telemonitoring of patients suffering from chronic heart failure by collecting, analysing, storing and visualising health data via a platform (webapp). A mobile application is provided to patients to collect data via compatible devices, or alternatively by manual entry of information into the application. Compatible devices are provided in a kit distributed by Newcard, consisting of a balance, a blood pressure monitor (with cuff) and a tablet to facilitate the collection of this information.

Level 3 plus

I am a CE-certified medical device
I am safely connected
I have proven my social-economic evidence and get reimbursed by NIHDI

Languages

EN FR NL
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General description
Additional info
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Financing

General description (provided by company)

Main purpose

1 Minute Pour Mon Cœur is a medical device software designed to remotely monitor
patients suffering from chronic heart failure by collecting, analyzing, storing and visualizing
health data.

Target audience

1 Minute pour mon Cœur is intended to be used by medical professionals, structure or
team of healthcare professionals (including at least one medical professional) who
provide medical follow-up for patients suffering from chronic heart failure.

The patient application is intended for patients suffering from chronic heart failure.

Approach

The 1 Minute pour mon coeur platform (webapp) is intended for use by healthcare professionals, and is made up of both medical and non-medical modules. The medical modules collect, visualize, and generate alerts based on patients' physiological parameters gathered via the mobile app (weight, arterial pressure, heart rate). Patients' lab analyses can also be monitored. This telemonitoring enables healthcare professionals, including or following a patient, to remotely consult and interpret the data required for the patient's medical follow-up and, if necessary, to make decisions relating to their care.

Connectivity to sensors and platforms

The platform recieves information from the Newcard patient app. The patient app is compatible with other patient information collection devices, and Newcard can provide patient kits with “iHealth” devices via Bluetooth (Android & iOS): blood pressure monitors and scales, to facilitate patient data collection.

Financing and pricing model

Financing model :
As part of its telemonitoring activity for heart failure patients, the Centre Hospitalier is remunerated by the INAMI. The terms and conditions of remuneration are set out in the above-mentioned Convention de télésurveillance et d'orientation thérapeutique de l'insuffisance cardiaque
chronique. The establishment contracts with the Newcard company on pricing conditions.
Pricing structure :
Our pricing model is based on a monthly fee per patient or end-user.
The amount of the fee may vary according to the options and functionalities chosen, such as whether or not the connected objects required for data collection are made available, or whether our nurses perform pre-screening

Adoption abroad

1 Minute pour mon cœur has been commercially available in France as a medical device
since 2019, and is currently reimbursed from the French health insurance system under the
List of Medical Telemonitoring Activities (LATM)

Pathology

Heart / Blood Vessels

Functions

Alerts & Notifications Data Sharing Health Tracking Remote Clinical Monitoring Treatment Support

Users

Men Women Elderly Clinicians

Additional info

Compliance to M3 criteria

This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:

Telemonitoring and therapy guidance in chronic heart failure ( More info: EN, NL, FR )

Compliance to M1 criteria

CE certification

Download document Granted by SGS Assessed and certified meeting the requirements of:
Medical Device Directive: MDD 93/42/EEC (old regulation) Medical Device Regulation: MDR 2017/745 (new regulation) In Vitro Diagnostic Directive: 98/79/EC (old regulation) In Vitro Diagnostic Regulation: IVDR 2017/746 (new regulation)
Certificate granted on 18/06/2025 Certificate valid till 31/12/2028 Class type of medical device (More info): 1
ISO Standards:
ISO 13485 Quality Management Systems for Medical Devices (on company level) ISO 14155 Clinical Investigations of Medical Devices in Human Subjects ISO 14971 Risk Management of Medical Devices ISO 27000 series: Information Security Management Systems ISO 62304 Medical Device Software Lifecycle Processes ISO 62366 Application of Usability Engineering to Medical Devices

FAMHP registration and notification

Company registration number at FAMHP: 74574 Product identification code at FAMHP: 988056

General Data Protection Regulation (More info)

Company declares explicitly to be compliant with GDPR rules Company declares that the data are stored in EU only

The app is only available through prescription

User instructions

The instructions for use are available to healthcare professionals directly via their account in the webapp. After inclusion, patients receive a quick guide that explains the functioning of the Newcard application and collection objects. This quick guide also has a QR code to the complete guide. Please contact Newcard to receive either of these instructions for use in paper or electronic form

Components of the application

Native appWeb applicationMedical device

Complaints handling

Via e-mail: cardio@newcard.io / contact@newcard.ioVia telephone: +33 (0) 3 20 14 71 14

Media

Financing

This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:

Telemonitoring and therapy guidance in chronic heart failure ( More info: EN, NL, FR )