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CE mark (MDR 2a) obtained for our Apilife solution
New medical devices implementation in Europe is contingent upon obtaining CE marking. Predict4Health was the first digital start-up to obtain CE marking under the new European MDR regulation for its Predigraft software, and now extends this certification to its Apilife telemonitoring software. This second marking confirms our position as a leader in the digital medical device industry. It is also an important step in the company's vision since it allows us to go beyond renal transplantation, and towards patients with chronic diseases on other organs.
Apilife is an easy-to-use solution that optimizes the management of patients with chronic diseases. By consolidating patients' clinical information and biological analysis results, Apilife offers a customizable remote medical monitoring system, backed by a messaging service and notification system. This system effectively facilitates the relationship between patients and healthcare professionals! Much appreciated by patients, therapeutic support content (recipes, recommendations, videos…) is also available on this platform.
Obtaining CE marking for Apilife is an ambitious milestone for the company, in the context of the new regulation (MDR 2017 745) on medical devices, and the existing bottleneck at the level of notified bodies, it is a real strategic advantage for Predict4Health to succeed in marking a second medical device in class IIa and to extend our scope. Predict4Health is now paving the way for other DM manufacturers to obtain CE marking.
Apilife’s implementation is already planned in several university hospitals, in partnership with several medical teams specialized in chronic heart, liver and lung failure.
About Predict4Health:
Predict4Health is a pioneer in the development of artificial intelligence-based software medical devices, offering its solutions to patients, healthcare professionals and the pharmaceutical industry. Predict4Health's ambition is to build the distribution platform for algorithms to prevent organ failure. Predict4Health's expertise in regulatory, clinical and infrastructure aspects of digital health solutions places it in a unique position to achieve this goal.
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