FDA Clears Epithelial Thickness Module for Heidelberg Engineering’s ANTERION Platform

Heidelberg Engineering has garnered U.S. Food and Drug Administration (FDA) clearance for the Epithelial Thickness Module, available exclusively through the ANTERION Cornea App. The module equips eye care professionals with advanced thickness mapping and data insights to evaluate the eye’s 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 various other cornea diagnostics.

“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,” Heidelberg Engineering USA General Manager Ram Liebenthal said. “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.”

Besides the Epithelial Thickness Module, ANTERION now includes Ectasia View, a powerful toolset designed to help clinicians assess and track ectatic cornea changes—even 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 United States since 2024, is a 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 Module and Ectasia View, ANTERION takes diagnostics to the next level, according to the company. These advanced features are helping transform daily clinical workflows, improve precision, and enhance efficiencies for clinicians.

“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,” principal trial investigator Jeffrey Fischer, M.D., noted. “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.”

The Epithelial Thickness Module is now commercially available. Existing ANTERION Cornea App users can add this module with a simple software update. For new customers, the module will be automatically integrated into the platform upon purchase of the ANTERION Cornea App.

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 products that deliver clinically relevant benefits. 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.