New module for ANTERION Cornea app receives US FDA clearance

Image credit: Heidelberg Engineering

Ophthalmic imaging and healthcare data solutions company Heidelberg Engineering has announced that its Epithelial Thickness Module, available through the ANTERION® Cornea app, has received US FDA clearance. The module provides eye care providers access to advanced, thickness mapping and data insights in order to evaluate epithelial and stromal structures.¹ With detailed parameters and color maps, the module supports refractive surgery planning, ocular surface evaluation, and corneal ectasia assessment, among other cornea diagnostics, according to a news release.

“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, in the release. “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.”

Additionally, ANTERION now includes Ectasia View, which allows eye care providers to assess and track ectatic changes in the cornea and monitor conditions including keratoconus. Corneal data is compiled from multiple visits into a single dashboard, which offers a quick overview of tomographic maps and parameters to aid in clinical decision making.¹

"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,” Jeffrey Fischer, MD, principal investigator of the clinical trial, stated in the release. “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."

Having been commercially available in the US since 2024, ANTERION has served as a modular anterior segment imaging platform combining biometry, IOL power calculation, corneal topography and tomography, anterior chamber metrics, and high resolution swept-source optical coherence tomography imaging.¹

The Epithelial Thickness Module is set to be commercially available in February 2025. Current ANTERION Cornea app users will be able to add the module with a software update once available. For new users, the module will be automatically integrated into the app’s platform upon purchase.¹

Reference:

1. FDA clears Epithelial Thickness Module for Heidelberg Engineering’s ANTERION multidisciplinary imaging platform, advancing precision in corneal health assessment. News release. Heidelberg Engineering. January 9, 2025. Accessed January 9, 2025.