FDA Clears Epithelial Thickness Module for Heidelberg Engineering’s Anterion Multidisciplinary Imaging Platform
Heidelberg Engineering has received FDA clearance for the Epithelial Thickness Module on the Anterion Cornea App. This module equips eye care professionals with advanced thickness mapping and data insights to evaluate both the epithelial and stromal structures, according to Heidelberg. 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.
“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,” Ram Liebenthal, General Manager of Heidelberg Engineering USA, said in a company news 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.”
In addition to the Epithelial Thickness Module, Anterion now includes Ectasia View, a toolset designed to help clinicians assess and track ectatic changes in the cornea, including conditions like keratoconus. This 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, which has been commercially available in the US 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.
"The Epithelial Thickness Module will be a valuable tool in improving precision and outcomes in cornea, cataract, and refractive care," said Jeffrey Fischer, MD, Principal Investigator of the clinical trial. "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 Module is set for February 2025. Existing Anterion Cornea App users can add this module with a software update. For new customers, the module will be automatically integrated into the comprehensive platform upon purchase of the Anterion Cornea App.