Betterise obtains class IIa CE mark for Oncolaxy and Cardiolaxy

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

January 2021

Betterise Health Tech, the French specialist in digital healthcare, whose customers include the Bordeaux University Hospital and the Valenciennes Hospital, has announced a major step in its development. The national laboratory for metrology and testing, via its subsidiary GMED, has officially obtained CE marking for its remote monitoring software: Oncolaxy and Cardiolaxy, Class IIa medical devices. This is less than a year after its ISO 13485 certification.

Digital health care represents a specific category of medical software: it has a concrete impact on patients' health and claims clinical benefits based on recognised clinical evaluations. Their design and distribution are regulated in the same way as medical devices used in healthcare: CE marking provides reassurance and guarantees their quality and safety. This is why digital care can be used to treat patients when they are at home, at a distance from a care facility.

Oncolaxy is a software for remote therapeutic management of cancer patients. Oncolaxy allows, thanks to a fine analysis of the evolution of symptoms reported by a patient (during and after treatment), to automatically detect relapses or complications related to therapies. 

Oncolaxy claims a longer life span for patients as well as a significant improvement of their quality of life, underlined by the digital therapeutic education that each user also receives in a personalised way. 

Oncolaxy is today the most advanced solution on the market, indicated for the monitoring of all cancers. It is the only class IIa remote oncology monitoring application capable of monitoring any treatment, including radio-chemotherapy, targeted therapies, immunotherapy, hormonal therapy, and organizing support care for solid and hematological tumors.

Cardiolaxy is a remote monitoring and clinical decision support tool in cardiology, allowing health care teams to remotely detect decompensations in patients suffering from heart failure through the analysis of bio-medical dynamics. Cardiolaxy claims a reduction in patient mortality and a decrease in rehospitalisation.

Digital care is making a real difference to patients' lives," says Florian Le Goff, director of prospective research for Betterise Health Tech. The first deployments in France and Germany confirm the clinical effectiveness of these devices. The support they provide to caregivers in the management of patients and the adaptation of support care in real time offer concrete prospects.

Oncolaxy and Cardiolaxy are currently the only digital health monitoring software in France with a CE class IIa certification. This marks a real breakthrough on the market: without this certification, a remote monitoring software is not allowed to process vital parameters (temperature, blood pressure...). 

Obtaining CE marking certificates for Class IIa Medical Devices requires the manufacturer to have the skills to design such software, with on-site inspections. It is necessary to demonstrate clinical benefit, and operational excellence for quality in a complex and costly audit process.

This is why there is now a real difference between the IT tools used in the Hospital Information System (e.g. Electronic Patient Records or Patient Portals) and the digital care offered by Betterise Health Tech. Under the new European regulation, a simple IT tool is not allowed to send alerts to a healthcare team if it is not certified as a class IIa medical device.

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

Obtaining CE marking for our two class IIa medical devices positions Betterise Health Tech as a major player in digital healthcare in Europe," said Paul-Louis BELLETANTE, President of the company. This recognition acknowledges the quality of the work carried out by our teams to offer caregivers in Europe reliable and secure remote therapeutic management services with recognised clinical benefits that are perfectly aligned with regulatory requirements.

About Betterise Health Tech:

Betterise Health Tech is an ISO 13 485 certified digital healthcare provider.

Its services assist caregivers in the remote therapeutic management of their patients, allowing secure monitoring of their data, automatic detection of complications thanks to CE-marked medical device-certified algorithms, and functionalities and content for digital therapeutic education of patients.

Based in Biarritz, the company has accompanied over 500,000 patients in 15 languages since 2013. A profitable company with a turnover in excess of €2M, it is independent and currently operates in the fields of oncology, cardiology, diabetes and nephrology. It also publishes primary prevention services on behalf of major companies.

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