German healthtech company deepeye Medical has achieved a significant regulatory milestone with the CE mark approval of its predictive artificial intelligence therapy planning assistant, deepeye TPS (Therapy Planning Support). The Class IIa medical device received certification from the EU Medical Device Regulation through Notified Body Kiwa Assurance, marking the first predictive AI assistant for therapy management in Europe.
Clinical Validation and Performance
The deepeye TPS system has demonstrated substantial clinical impact through extensive validation. The AI assistant has been trained on thousands of patient cases from more than 200 retina centers across Europe. Clinical validation has been supported through collaboration projects with major pharmaceutical companies including Novartis, Bayer, and Roche.
The system's development was inspired by the IVI-Portal of the Eye Center at St. Franziskus-Hospital Münster, which achieved remarkable clinical outcomes. When conducting double readings of optical coherence tomography (OCT) imaging, the portal helped triple visual acuity gains and double therapy adherence compared to other real-world studies.
Technology and Workflow Integration
The deepeye TPS system is designed specifically for neovascular age-related macular degeneration (AMD) treatment planning. Medical assistants can upload spectral domain OCT scans through the system with just one to two clicks. The AI assistant then analyzes the automatically pseudonymized OCT data and generates comprehensive reports.
The generated reports include several key components: assessment of disease activity for immediate therapy decision support, biomarker visualization to explain AI recommendations, 12-month therapy need prognosis to support patient education, trend diagrams showing therapy progress, and text summaries to accelerate documentation processes.
Market Access and Platform Integration
The AI assistant is currently available through Heidelberg Heyex2 AppWay, with deepeye Medical planning to expand connections to additional OCT imaging platforms including Topcon Harmony and ZEISS FORUM. The company emphasizes the system's cost-effectiveness, compatibility with all common OCT devices, and user-friendly interface for medical staff.
"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."
Addressing Clinical Challenges
The deepeye TPS system is designed to address a critical gap between real-world outcomes and clinical trial data by reducing patient dropout rates. The AI assistant aims to enhance both the efficiency and effectiveness of intravitreal injection therapy planning, potentially improving overall treatment outcomes for AMD patients.
The company plans to leverage its partnerships to make deepeye TPS available globally once regulatory approval is achieved in countries outside of Europe. This expansion strategy reflects the growing demand for AI-powered solutions in ophthalmology practice management.
Research Platform Development
Beyond the therapy planning assistant, deepeye Medical has developed deepeye Research, an AI solution designed to empower retinal therapy study teams with actionable insights from complex datasets. This research platform builds on proven methodologies involved in major phase 3 and phase 4 anti-VEGF trials in the EU.
The research solution operates within four pillars of advanced retinal research: comprehensive data input, anonymized and standardized output, an AI platform for research, and AI-powered insights. The system integrates with large, heterogeneous OCT imaging and clinical datasets to produce anonymized, standardized, and enhanced imaging data for research applications.
