Heidelberg Engineering has received FDA 510(k) clearance for the Epithelial Thickness Module, accessible exclusively via its ANTERION Cornea App, an anterior segment imaging platform.
Let’s start with ANTERION.
Cleared by the FDA in October 2023, the ANTERION platform became commercially available in the United States in 2024.
What it is: An upgradable imaging platform designed to provide high-resolution visualization of the entire anterior segment in just one device.
How it does this: By incorporating biometry and intraocular pressure (IOP) power calculation with key diagnostic technologies such as:
- Corneal topography
- Corneal tomography
- High-resolution imaging
- Anterior chamber metrics
- High-resolution swept-source (SS) optical coherence tomography (OCT)
Learn about its unique features and components by clicking here.
Next: Talk about the platform’s Cornea App.
One of four apps available on the ANTERION—the other three: imaging, cataract, and metrics—the ANTERION Cornea App gives eyecare practitioners (ECPs) a more comprehensive diagnostic solution for evaluating patients’ corneal geometry.
Such capabilities extend to:
- Diagnosing or monitoring corneal alterations
- Advanced refractive surgery planning / evaluation
- Analysis of total corneal power, pachymetry, and corneal wavefront
And how does this Epithelial Thickness Module come into play?
This (as we mentioned) ANTERION Cornea App-exclusive module provides “advanced, thickness mapping and data insights,” that allows ECPs to analyze epithelial and stromal structures.
Also included: Detailed parameters and color maps with components designed to:
- Support refractive surgery planning
- Assess ocular surface evaluation
- Aid in corneal ectasia assessment
- Assist in other corneal diagnostics
Specifically: The module is noted as a “valuable tool” for improving precision and outcomes in cornea, cataract, and refractive care as well as “detailed, repeatable data that are essential for evaluating and managing various corneal conditions and procedures,” stated Jeffrey Fischer, MD, principal investigator of the module’s FDA-clearing clinical study.
Nice! Now what else should we know?
FDA clearance aside, Heidelberg also announced that the ANTERION platform will feature Ectasia View, an advanced feature for assisting ECPs in evaluating and tracking ectatic changes within the cornea (such as in keratoconus).
In addition: The new toolset integrates vital corneal data from multiple patient visits (from both eyes) into a single and intuitive diagnostic dashboard.
- The intended result: A quick overview of essential tomographic maps and parameters to enable clinical decision-making.
So when will the Epithelial Thickness Module be available?
Heidelberg reported the module will be available for commercial use in the United States in February 2025 (less than a month away!).
For new customers: The module will be automatically integrated into the ANTERION platform when they purchase the ANTERION Cornea App.
And what if I already own this platform?
Existing customers will simply need to update their software to add the module.