deepeye Medical Secures CE Mark for AI-Based Retinal Therapy Planning Tool

deepeye Medical has announced CE Mark approval for its AI-powered Therapy Planning Support platform, deepeye TPS, marking a significant regulatory milestone under the EU Medical Device Regulation (MDR 2017/745). The platform, now certified as a Class IIa medical device by Notified Body Kiwa Assurance, is designed to improve planning and adherence in retinal disease treatment.

Addressing Gaps in Real-World Anti-VEGF Outcomes

While anti-VEGF therapies for conditions such as wet age-related macular degeneration (AMD) have demonstrated success in clinical trials, real-world outcomes often fall short. Many patients discontinue treatment prematurely, leading to preventable and irreversible vision loss.

deepeye TPS aims to address these discrepancies by enhancing the efficiency and quality of intravitreal injection (IVI) therapy planning in everyday clinical practice.

Clinical Origins and Validation

The platform was inspired by the IVI-Portal of the Eye Center at St. Franziskus-Hospital Münster, where a double reading of OCT imaging has been shown to:

       • Triple visual acuity gains

       • Double therapy adherence (compared to other real-world data sets)

The AI model behind deepeye TPS has been trained on thousands of patient cases from over 200 retina centers, and validated in collaboration with industry leaders including Novartis, Bayer, and Roche.

Key Features of deepeye TPS

With a user-friendly workflow, medical assistants can upload SD-OCT scans from wet AMD patients to the AI platform with just 1–2 clicks. The AI then analyzes pseudonymized images and provides a detailed report including:

       • Assessment of disease activity for immediate therapy decision support

       • Visualization of biomarkers for explainability and clinical transparency

       • 12-month therapy need prediction to inform and engage patients

       • Trend diagrams to monitor therapy progress over time

       • Auto-generated text summary to streamline clinical documentation

These tools are intended to support the doctor-AI assistant team, helping clinicians optimize treatment strategies and outcomes, while also improving clinic efficiency and financial sustainability.

Benefits for Retina Clinics

deepeye TPS delivers several operational advantages:

       • Expert Time Savings: Aids in planning and patient education

       • User-Friendly Design: Simple and intuitive for medical staff

       • Device Compatibility: Works with OCT scans from all major imaging platforms

       • Cost-Effective Implementation: Offers high ROI for IVI centers with high patient volume

Industry Perspective and Future Integration

“This regulatory milestone of the first predictive AI assistant for therapy management shows that Europe can be innovative,” said Manuel Opitz, CEO of deepeye Medical.
“We are happy to offer ophthalmologists across Europe our AI assistant, supported by our partners, in their daily work of driving clinical outcomes and therapy adherence.”

Integration and Scalability

deepeye TPS is currently available through Heidelberg Heyex2 AppWay, with upcoming integrations for:

       • Topcon Harmony

       • Zeiss FORUM

       • Additional OCT platforms

These connections are designed to support global scalability as the company prepares for regulatory expansion beyond Europe, aiming to bring AI-driven therapy support into ophthalmology practices worldwide.

References

 deepeye TPS is a CE-marked medical device. In addition, it complies with the EU AI Act regarding full transparency, human oversight, and explainability. Important information regarding the scope and limitations of the trained algorithm is indicated in the electronic instructions for use.

 Currently only accessible with HEYEX 2.6+, soon other imaging platforms