May 21, 2025
Munich, Germany – May 21, 2025 — deepeye Medical announces that deepeye® TPS¹ (Therapy Planning Support) has received CE mark (Class IIa) under the EU Medical Device Regulation (MDR 2017/745), following certification by the Notified Body Kiwa Assurance. This marks a major regulatory milestone for medical AI - not just in ophthalmology - and paves the way for rollout across Europe.
Despite the clinical success of anti-VEGF therapy for retinal diseases like neovascular age-related macular degeneration (nAMD), 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. 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.
The workflow is seamless: medical assistants send SD-OCT scans of nAMD 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:
The new dream team of doctor and AI assistant has the potential to optimise treatment strategies and improve patient outcomes, and thereby improve the financial stability of clinics. Overall, deepeye® TPS provides the following advantages:
“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.”
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
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
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deepeye Medical is a German healthtech company committed to preventing avoidable blindness from retinal diseases. With its CE-certified AI assistant, deepeye provides real-time, predictive therapy support to ophthalmologists, combining clinical precision with intuitive usability. The company partners with global pharma leaders, imaging manufacturers, and retina specialists to bring precision medicine to retinal therapy worldwide.
