CE-Mark Granted to deepeye Medical for AI Tool for Retinal Therapy Planning

deepeye Medical has received CE Mark for its deepeye TPS¹ (Therapy Planning Support) platform. 

The Class IIa approval was made under the EU Medical Device Regulation (MDR 2017/745), following certification by the Notified Body Kiwa Assurance. 

According to deepeye, despite the clinical success of anti-VEGF therapy for retinal diseases like wet age-related macular degeneration (AMD), real-world outcomes often lag behind trial data. Many patients discontinue therapy prematurely, leading to irreversible vision loss. deepeye TPS is designed to close this gap by enhancing both the efficiency and potentially the effectiveness of intravitreal injection (IVI) therapy planning in daily practice.

deepeye Medical was inspired by the IVI-Portal of the Eye Center at St. Franziskus-Hospital Münster, where double reading of OCT imaging has tripled visual acuity gains and doubled therapy adherence compared to other real-world studies, according to a company news release. deepeye TPS was trained on thousands of patient cases from more than 200 retina centers. It has been clinically validated, for instance in collaboration projects with Novartis, Bayer, and Roche.

According to deepeye, medical assistants send SD-OCT scans of wet AMD patients to the AI with just 1-2 clicks. The AI assistant then analyzes the automatically pseudonymized OCT and generates a report with the following information:

• Assessment of disease activity for one-glance therapy decision support
• Biomarker visualization for explainability of AI recommendation
• 12-month therapy need prognosis to support patient education
• Trend diagrams on therapy progress²
• Text summary for accelerated documentation

The team of doctor and AI assistant has the potential to optimize treatment strategies and improve patient outcomes, and thereby improve the financial stability of clinics. deepeye TPS provides the following advantages:

• Expert Time Savings: Supports treatment planning and patient education
• User-Friendly: Simple operation for medical staff
• Compatibility: Processes OCT images from all common OCT devices‍
• Cost-Effectiveness: High ROI for busy IVI centers

“This regulatory milestone of the first predictive AI assistant for therapy management shows that Europe can be innovative,” Manuel Opitz, CEO of deepeye Medical, said in a news release. “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.”

deepeye TPS is available via Heidelberg Heyex2 AppWay, with upcoming connections for Topcon Harmony, Zeiss FORUM, and other OCT imaging platforms. These partnerships allow global scalability into every ophthalmic practice, once regulatory approval stretches beyond Europe.

For more information, visit: www.deepeye-medical.com

‍References

¹ 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.

² Currently only accessible with HEYEX 2.6+, soon other imaging platforms