FDA Clears Epithelial Thickness Module for Heidelberg Engineering’s ANTERION® Multidisciplinary Imaging Platform, Advancing Precision in Corneal Health Assessment
FRANKLIN, Mass. – Heidelberg Engineering, a global leader in ophthalmic imaging and healthcare data solutions, is pleased to announce FDA clearance of the Epithelial Thickness Module, available exclusively through the ANTERION Cornea App. This innovative module equips eye care professionals with advanced, thickness mapping and data insights to evaluate both the epithelial and stromal structures. Featuring detailed parameters and color maps, the module is designed to support refractive surgery planning, assess ocular surface evaluation, aid in corneal ectasia assessment, and assist in a variety of other cornea diagnostics.
“From the beginning, our vision has been to provide precise data and reproducible measurements that allow clinicians to make informed decisions, enhance patient care, and streamline workflows. This latest FDA clearance is a key milestone in fulfilling that mission.”
“With the FDA clearance of the Epithelial Thickness Module, we are excited to expand the capabilities of the ANTERION® Cornea App and provide eye care professionals with an even more robust toolkit for assessing their patients’ corneal health,” said Ram Liebenthal, General Manager of Heidelberg Engineering USA. “From the beginning, our vision has been to provide precise data and reproducible measurements that allow clinicians to make informed decisions, enhance patient care, and streamline workflows. This latest FDA clearance is a key milestone in fulfilling that mission.”
In addition to the Epithelial Thickness Module, ANTERION now includes Ectasia View, a powerful toolset designed to help clinicians assess and track ectatic changes in the cornea, including conditions like keratoconus. This advanced feature integrates vital corneal data from multiple visits into a single, intuitive dashboard, offering a quick overview of essential tomographic maps and parameters to facilitate clinical decision-making.
ANTERION, commercially available in the U.S. since 2024, is a leading-edge modular anterior segment imaging platform that combines biometry, IOL power calculation, corneal topography and tomography, anterior chamber metrics, and high-resolution swept-source OCT imaging into a single device. With the added capabilities of the Epithelial Thickness Moduleand Ectasia View, ANTERIONtakes diagnostics to the next level. These advanced features are helping to transform daily clinical workflows, improve precision, and enhance efficiencies for clinicians.
Jeffrey Fischer, MD, Principal Investigator of the clinical trial, shared, “The Epithelial Thickness Module will be a valuable tool in improving precision and outcomes in cornea, cataract, and refractive care. It provides detailed, repeatable data that are essential for evaluating and managing various corneal conditions and procedures. The enhanced Ectasia View will be particularly helpful for monitoring conditions like keratoconus, making it easier to track progression. Together, these features support better patient care and more effective treatment planning.”
Commercial availability of the Epithelial Thickness Moduleis set for February 2025. Existing ANTERION Cornea Appusers can easily add this module with a simple software update. For new customers, the module will be automatically integrated into the comprehensive platform upon purchase of the ANTERION Cornea App.
For more information about ANTERION, visit our website or contact us directly.
About Heidelberg Engineering
Heidelberg Engineering continuously optimizes imaging and healthcare IT technologies to provide ophthalmic diagnostic solutions that empower clinicians to improve patient care. From its inception in 1990, the Company has collaborated with scientists, clinicians, and industry to develop innovative products that deliver clinically relevant benefits.
Uncompromising quality and education play a large part in fostering the diagnostic confidence that has become synonymous with the global brand. The Company’s substantial expertise in the development and implementation of intelligent image and data management solutions complements its distinguished history in the design, manufacture, and distribution of ophthalmic diagnostic instruments.
Heidelberg Engineering’s growing product portfolio combines these core technologies: confocal microscopy, scanning lasers and optics, optical coherence tomography (OCT), real-time image processing and analytics, multimodal image management solutions (PACS), electronic medical records (EMR), and large-scale data analysis.
