Cibiltech09.21.21
Cibiltech, a start-up specializing in predictive medicine software, announced that its Predigarft product has received CE marking as a class IIa medical device under the new European MDR regulation.
Predigraft—Cibiltech's first medical device—is a software predicting individual long-term kidney allograft survival and improving the management of transplant patients.
Hélène VIATGE, Cibiltech's managing director, said: "Predigraft's CE marking is a major milestone for Cibiltech and I am very proud to announce that Cibiltech is the first French company to have officially received class IIa marking under the new regulation for a 100% digital solution. Software such as Predigraft are now considered as medical devices with the same standards and quality requirements, for the benefit of patients and healthcare professionals. The work conducted by Manon MARAULT, our Quality and Regulatory Manager, and her team is colossal and this recognition by our notified body undoubtedly opens a very promising new chapter for the company."
The CE marking allows the company to market its medical device in all countries that recognize this certification, including all countries of the European Union.
Predigraft was created based on the iBox technology, an algorithm developed by the Paris Transplant Group (INSERM UMR 970 / AP-HP / University of Paris), which gives the probability that the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.
Cibiltech is a pioneer in the development of artificial intelligence-based software medical devices, offering its solutions to patients, healthcare professionals and to the pharmaceutical industry. Cibiltech's ambition is to build the distribution platform for algorithms to prevent organ failures. Cibiltech's expertise in the regulatory, clinical and infrastructure aspects of digital health solutions places it in a unique position to achieve this goal.
Predigraft—Cibiltech's first medical device—is a software predicting individual long-term kidney allograft survival and improving the management of transplant patients.
Hélène VIATGE, Cibiltech's managing director, said: "Predigraft's CE marking is a major milestone for Cibiltech and I am very proud to announce that Cibiltech is the first French company to have officially received class IIa marking under the new regulation for a 100% digital solution. Software such as Predigraft are now considered as medical devices with the same standards and quality requirements, for the benefit of patients and healthcare professionals. The work conducted by Manon MARAULT, our Quality and Regulatory Manager, and her team is colossal and this recognition by our notified body undoubtedly opens a very promising new chapter for the company."
The CE marking allows the company to market its medical device in all countries that recognize this certification, including all countries of the European Union.
Predigraft was created based on the iBox technology, an algorithm developed by the Paris Transplant Group (INSERM UMR 970 / AP-HP / University of Paris), which gives the probability that the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.
Cibiltech is a pioneer in the development of artificial intelligence-based software medical devices, offering its solutions to patients, healthcare professionals and to the pharmaceutical industry. Cibiltech's ambition is to build the distribution platform for algorithms to prevent organ failures. Cibiltech's expertise in the regulatory, clinical and infrastructure aspects of digital health solutions places it in a unique position to achieve this goal.
