FDA Clears Epithelial Thickness Module for Heidelberg Engineering's Anterion Imaging Platform

Heidelberg Engineering has received FDA clearance for the new Epithelial Thickness Module on its Anterion Cornea App, enhancing diagnostic capabilities for eye care professionals. This module provides advanced thickness mapping and data insights to assess both epithelial and stromal structures, supporting various corneal diagnostic and surgical planning needs.

Key Features of the Epithelial Thickness Module

The Epithelial Thickness Module is equipped with:

       • Detailed parameters and color maps for in-depth corneal assessment.

       • Tools to aid in:

               - Refractive surgery planning.

               - Ocular surface evaluation.

               - Corneal ectasia assessment, including conditions like keratoconus.

               - General cornea diagnostics.

Expanding Capabilities in Corneal Health

“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.

"Our vision has always been to deliver precise data and reproducible measurements, enabling clinicians to make informed decisions, enhance patient care, and streamline workflows. This FDA clearance represents a key milestone in fulfilling that mission."

Enhanced Corneal Diagnostic Tools

In addition to the Epithelial Thickness Module, the Anterion Cornea App now includes:

       • Ectasia View: A comprehensive toolset to assess and monitor ectatic changes, including keratoconus.

               - Integrates corneal data from multiple visits into an intuitive dashboard.

               - Provides essential tomographic maps and parameters for efficient clinical decision-making.

The Anterion Platform

Anterion, available in the U.S. since 2024, is a modular anterior segment imaging platform offering:

       • Biometry.

       • IOL power calculation.

       • Corneal topography and tomography.

       • Anterior chamber metrics.

       • High-resolution swept-source OCT imaging.

Advancing Corneal, Cataract, and Refractive Care

According to Jeffrey Fischer, MD, Principal Investigator of the clinical trial:

"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.”

Availability

       • Commercial Launch: February 2025.

       • Existing Anterion Cornea App users can access the Epithelial Thickness Module via a software update.

       • New customers will have the module integrated into the platform upon purchase.

Heidelberg Engineering continues to innovate in corneal health, offering tools that empower clinicians to improve outcomes and streamline workflows, setting a new standard in ophthalmic care.