Betterise obtains Class IIa CE marking for Oncolaxy and Cardiolaxy

CE certification for our medical remote monitoring and diagnostic support software.

January 2021

Betterise Health Tech, the French specialist in digital care, whose customers include Bordeaux University Hospital and Valenciennes Hospital Centre, announces a major milestone in its development. The National Metrology and Testing Laboratory, via its subsidiary GMED, has formally issued the CE mark for its remote monitoring software: Oncolaxy and Cardiolaxy, Class IIa Medical Devices. This is less than one year after they received their ISO 13485 certification.

Digital care is a specific category of medical software that has a concrete impact on patient health and produces clinical benefits based on recognised clinical evaluations. The design and distribution of digital care are regulated in the same way as the medical devices used in care: the CE mark provides reassurance and guarantees their quality and safety. It is for this reason that digital care can be used to manage patients while they are at home, away from a healthcare facility.

Oncolaxy is a remote therapeutic management software package for cancer patients. Thanks to a precise analysis of the evolution of symptoms reported by patients (during and after the treatment), Oncolaxy makes it possible to detect recurrence or complications related to therapies automatically. 

Oncolaxy claims an extension of patient survival as well as a significant improvement in their quality of life, complemented by the personalised digital therapeutic education that each user also receives.  

Oncolaxy is the most advanced solution available on the market today and is indicated for the follow-up of all cancers. It is the only Class IIa remote monitoring application in oncology capable of monitoring any treatment, including radio-chemotherapy, targeted therapy, immunotherapy and hormone therapy, as well as organising supportive care for solid and haematological tumours.

Cardiolaxy is a remote monitoring and clinical decision support tool in cardiology, allowing care teams to detect decompensation remotely in heart failure patients through the analysis of biomedical dynamics. Cardiolaxy claims decreased patient mortality and reduced rehospitalisation.

Digital care is changing patients’ lives in concrete ways," emphasises Florian Le Goff, director of prospective research at Betterise Health Tech. The first deployments in France and Germany have confirmed the clinical efficacy of these devices. The support they provide to caregivers in patient management and the adaptation of supportive care in real time offer very real prospectsaptation of support care in real time offer concrete prospects.

Oncolaxy and Cardiolaxy are among only a few remote monitoring software packages in France in the digital care field bearing the class IIa CE mark. This constitutes a real breakthrough in the market, because without this certification, remote monitoring software is not authorised to process vital parameters (temperature, voltage, etc.).  

Obtaining CE mark certifications for Class IIa Medical Devices means that the manufacturer is recognised as possessing the skills required to design such software, with on-site inspections. It is necessary to demonstrate the clinical benefit and operational excellence with a focus on quality in a complex and costly audit process.

For this reason, there is a real difference today between the IT tools used in the Hospital Information System (for example Electronic Patient Records or Patient Portals) and the digital care offered by Betterise Health Tech. In the context of the new European Regulation, a simple IT tool is not authorised to send alerts to a care team unless it is certified as a Class IIa Medical Device.

The absence of certification for certain solutions currently used in the field poses a significant medico-legal risk to physicians who use them. Betterise Health Tech is thus contributing to a much-needed transformation of the digital health industry.

Obtaining the CE mark for our two Class IIa medical devices positions Betterise Health Tech as a key player in digital care in Europe," says Paul-Louis BELLETANTE, CEO of the company. This certification recognises the quality of the successful work done by our teams in offering European caregivers reliable, secure remote therapy management services with recognised clinical benefits, which are also perfectly aligned with regulatory requirements.

About Betterise Health Tech:

Betterise Health Tech is an ISO 13485-certified digital care publisher.

Its services assist caregivers in the remote therapeutic management of their patients, by allowing secure monitoring of patient data, automatic detection of complications thanks to certified algorithms, medical devices bearing the CE mark and functionalities and content facilitating digital therapeutic patient education.

Based in Biarritz, the company has supported more than 500,000 patients in 15 languages since 2013. As a profitable, independent company with a turnover of more than €2 million, Betterise today operates in the fields of oncology, cardiology, diabetology and nephrology. It also publishes primary prevention services on behalf of large companies.

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