Heidelberg Engineering’s latest FDA-cleared technology looks to make strides in corneal evaluation.
Heidelberg Engineering (Heidelberg, Germany) has received FDA clearance for the firm’s Epithelial Thickness Module.
Set to launch in February 2025, this advanced module will bring new capabilities to clinicians, offering detailed thickness mapping and data insights to evaluate both the epithelial and stromal structures of the cornea.
The Module will be made available exclusively through the ANTERION® Cornea App.
“With the FDA clearance of the Epithelial Thickness Module, we are excited to expand the capabilities of the ANTERIOR® 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.
“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,” he added.
So, what does this mean for eye care? With its precise color maps and detailed parameters, the new Epithelial Thickness Module supports a wide range of diagnostics and treatments. From planning refractive surgery to assessing corneal ectasia and evaluating the ocular surface, this module is designed to enhance both decision-making and patient outcomes.
General Manager of Heidelberg Engineering USA, Ram Liebenthal, shared his enthusiasm for this milestone: “With the FDA clearance of the Epithelial Thickness Module, we are excited to expand the capabilities of the ANTERION Cornea App. Our goal has always been to provide precise, reproducible data that supports informed clinical decisions, improves patient care, and streamlines workflows. This latest clearance is a significant step in that direction.”
Ectasia View‘s approach to keratoconus monitoring
In addition to the Epithelial Thickness Module, the ANTERION platform now includes Ectasia View—a new feature designed to help clinicians monitor and track ectatic changes in the cornea, such as keratoconus.
Ectasia View consolidates essential data from multiple visits into one intuitive dashboard, simplifying the process of tracking disease progression and supporting more effective treatment planning
Dr. Jeffrey Fischer, principal investigator of the clinical trial, emphasized the importance of these updates: “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.”
ANTERION: A comprehensive platform for corneal health
ANTERION is Heidelberg’s modular anterior segment imaging platform that’s been commercially available in the U.S. since 2024. It combines high-resolution swept-source OCT imaging, biometry, IOL power calculation, corneal topography and tomography, and anterior chamber metrics—all in one device.
