CE-Mark

CE-Mark

by | 30 Aug. 24 | Certificates

The CareLine Platform is a Class I software as a medical device (SaMD) intended for healthcare professionals to enable remote management of heart failure patients.

The CareLine Platform is on the French Assurance Maladie’s reimbursement list for medical remote monitoring activities. Coverage is conditional to the activities being operated by a declared remote monitoring operator and to the patient following a therapeutic educational program.

Read carefully the healthcare professional instructions for use.

The CareLine Platform is CE-marked as Class I under Directive 93/42/EEC (MDD). In accordance with Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 (MDR), this CE-marking is valid until 31 December 2028 as a result of Article 120(3b). A Class IIa certification procedure under MDR is ongoing.
French Digital Health Agency certification

French Digital Health Agency certification

by | 11 Dec. 23 | Certificates, Corporate

The CareLine Platform has been certified by the French Digital Health Agency (Agence du Numérique en Santé – ANS) to comply with the interoperability and security common specifications for digital medical devices and the French HTA (Haute Autorité de Santé – HAS) common specifications for “heart failure remote monitoring”. Therefore, it has been included in the list of certified solutions published by ANS. This certification ensures compliance with regulatory requirements for the implementation of remote monitoring to the benefit of heart failure patients under care.
To that effect, the CareLine Platform integrates the most recent technologies of the core services included in the national the digital health doctrine, including the Pro Santé Connect authentification, synchronization with the National HCP Directory through a FHIR API or certificate-based authentication to interrogate the INSi service. With this certification, CareLine Solutions demonstrates its commitment to healthcare professionals in supporting innovative medical practices. The CareLine Platform certification by ANS also enables its coverage by French Health Insurance (Assurance Maladie) with a dedicated code for remote monitoring systems. This dedicated code has been included in the list provided for in Article L. 162-51 of the Social Security Code. Learn more on ANS website.
Remote management of worsening heart failure

Remote management of worsening heart failure

by | 6 Nov. 23 | Scientific publications

The article Remote management of worsening heart failure to avoid hospitalization in a real-world setting, published in ESC Heart Failure, presents the results of the real-life retrospective clinical study on 161 heart failure patients managed remotely by the Bordeaux University Hospital over a period of 291±66 days.

Whereas remote monitoring of Heart Failure is a general concept focused mainly on the early detection of Worsening Heart Failure events, remote management is a more comprehensive approach that encompasses prevention, detection, and remote care. This is a critical difference, because remote care has the potential to decrease hospitalization.

Thanks to multiparametric remote monitoring using connected devices and performed by a specialized hospital care team, a strategy for remote management of episodes of worsening heart failure can be implemented:
With this approach, nearly 2/3 of episodes of worsening heart failure could be managed remotely, avoiding hospitalization:

In the present study, most Worsening Heart Failure events (62.9%) could be successfully managed remotely.

Authors conclude:

Our study suggests that remote management of Worsening Heart Failure events based on a multiparametric approach led by a telemedical centre is feasible and safe. Adopting such a strategy for patients with chronic Heart Failure could reduce Heart Failure-related hospitalizations with expected benefits for patients, care providers, and health care systems.

The full article is available here (open access).

ISO 13485 certification

ISO 13485 certification

by | 12 Jul. 23 | Certificates, Corporate

As part of its implementation plan of the new European regulation on medical devices1, CareLine Solutions has obtained certification that its management system complies with the ISO 13485:2016 standard for the design, development and marketing of digital solutions in the context of medical care.

This certification, valid for 3 years and subject to an annual audit, was issued on 12 July 2023 by Bureau Veritas Certification France. It attests to the consideration of customer requirements, current regulations and the ability to understand new technologies and market opportunities.

The ISO 13485:2016 standard, specific to medical devices, takes into account the specific requirements of this field, in particular with regard to compliance with regulatory requirements, risk management and control, control of the design process and traceability.

1. Regulation (EU) 2017/745 on medical devices