An innovative biomedical company, deepeye Medical GmbH, based in Munich Germany, has received a regulatory CE mark (Class IIa) service for a novel AI tool to provide retinal therapy planning of intravitreal injections (IVI) to support ophthalmologists managing treatments for anti-VEGF therapy for nAMD patients. The AI initiative, regulating the EU Medical Device Regulation (MDR 2017/745), received certification by the Notified Body Kiwa Assurance. According to the company, the “deepeye® TPS (Therapy Planning Support)” tool provides “a major regulatory milestone for medical AI – not just in ophthalmology – and paves the way for rollout across Europe.”
deepeye Medical outlines that while anti-VEGF therapy for retinal diseases have made an enormous benefit for the treatment of neovascular age-related macular degeneration (nAMD), “real-world outcomes often lag behind trial data”. According to the company, “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.”
A busy clinic may be able to send spectral domain OCT scans to the company and their AI tool will automatically analyse pseudonymised OCT and generate a report providing an assessment of disease for each individualised patient. The data can then advise and support decision making, biomarker visualisation and an AI recommendation. The company engages with the ophthalmologists “to optimize your IVI therapy planning”, presenting the world’s first AI assistant to support the ophthalmologist with a second reading of every OCT. deepeye Medical worked with the Eye Center at St. Franziskus-Hospital Münster, showed that “double reading of OCT imaging has tripled visual acuity gains and doubled therapy adherence compared to other real-world studies.” The company stated that the AI tool “was trained on thousands of patient cases from more than 200 retina centres” and “clinically validated, for instance in collaboration projects with Novartis, Bayer, and Roche.”
The announcement of the CE mark provides the first predictive AI tool for therapy planning for nAMD patients and the CEO of the company, Manuel Opitz, stated that, “this regulatory milestone of the first predictive AI assistant for therapy management shows that Europe can be innovative. 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.
Scientific advisors of the technology include, Prof. Dr. med Albrect Lommatzsch, Univ. Prof. Dr. med. Siegfried Priglinger and Prof. Dr. Adam Dubis:
