#OphtAI gets CE Medical Device Certification

4 April 2019
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#OphtAI, the new #AI product line of #Evolucare and #ADCIS, gets CE Medical Device Certification.

Our Artificial Intelligence, now available for clinical use, identifies diabetic retinopathy from a mere retina fundus image with performances on par with the best retina ophthalmology specialists.

Great challenges ahead

There are 425 million people with diabetes worldwide (1 in 11 adults), with a projected increase to 600 million by 2035. It is estimated that 30 to 50% of people with diabetes suffer from diabetic retinopathy. The WHO recommends an annual screening, which means 2.3 million eyes to be analyzed every day!

To face this challenge, a funduscopic dilated eye exam performed by an ophthalmologist cannot be the only solution, which is why the tele-screening is quickly gaining ground.

In terms of organization, delegating tasks has already proven its effectiveness. However, today, we still face many challenges:

– there is a lack of qualified professionals to perform tele-screening,

– long and tedious traditional methods are widely used,

– there is a lack of regulation to allow tele-screening in some countries.

All these points need to be resolved to provide early and effective care for all patients (mass screening).

A solution to meet the challenge

To that purpose, we have developed a decision support algorithm that allows all screening professionals to carry out their activity on par with the best retina experts. It was developed by analyzing a database of several hundred thousand retinas, a database which was created by the largest French tele-screening network within the Parisian hospital network (Hôpitaux de Paris (AP-HP)).

Our solution is a certified medical device designed for:

–          the organization of screening campaigns, thanks to a platform hosted by geographical area which is accessible anywhere by Internet and which allows :

  • The work to be organized in sub-networks and the networking of stakeholders
  • possible integration with hospital IT systems
  • the creation of a patient record (profile, clinical context)
  • automatic photo integration (DICOM)
  • picture archiving (PACS) and patient follow-up over time
  • automatic sending of reports
  • a patient file to be accessible at any time by Internet.

–        Assistance with screening through Artificial Intelligence that works with any type of fundus camera and that indicates:

  • to the operator / screener : in real time, if the retina image will be able to be interpreted
  • to the person reading the results : within a few seconds,
    • the severity of the Diabetic Retinopathy,
    • the mapping of the lesions,
    • the course of action (degree of urgency),
    • the associated pathologies,
    • and the level confidence.


To learn more about our solution, come and meet us at French Society of Ophtalmology (#SFO) International Congress, from 11 to 14 of May in Paris. We will showcase there in exclusivity our complete offer for the optimization of screening operations and daily ophthalmology practices.

Many thanks to all of our collaborators, partners and supports : AP-HP, Assistance Publique – Hôpitaux de Paris, #LATIM, Pr @Pascale MASSIN, Pr @Béatrice Cochener, Dr @jean Bernard ROTIER, @ Vincent Gualino @SATT Ouest Valorisation, @systematic @medicen, Région Île-de-France, @Bpifrance.


To learn more : https://www.evolucare.com/en/eye-care/?region=eur

Join our team : https://www.linkedin.com/jobs/search/?f_C=4828623&locationId=OTHERS.worldwide