Heidelberg Engineering announces FDA clearance for ANTERION Epithelial Thickness Module, Ectasia View

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In a press release, Heidelberg Engineering announced the US Food and Drug Administration (FDA) has issued clearance for the company’s Epithelial Thickness Module, available within the ANTERION Cornea App.¹ The module enables advanced thickness mapping, detailed parameters, color maps and data insights to help clinicians evaluate the epithelial and stromal structures. The imaging platform and the new module will support a number of clinical needs including refractive surgery planning, assessment of the ocular surface, evaluation of corneal ectasia and diagnosis of other cornea conditions.

In addition, the ANTERION platform introduced Ectasia View, a toolset designed for diagnosing and monitoring cornea changes, especially due to conditions such as keratoconus. Heidelberg Engineering explained that the Ectasia View tool integrates data from multiple visits into a one dashboard for an at-a-glance view of tomographic maps and other findings.¹

The Epithelial Thickness Module is expected to be commercially available in February 2025. According to Heidelberg Engineering, existing ANTERION Cornea App will be able to add the module with a software update. The module will be automatically integrated into the ANTERION platform for new users of the Cornea App.

The ANTERION platform received FDA clearance in October 2023 and has been commercially available in the US since 2024.² In 2018, it received CE Mark approval in Europe. A suite of apps was cleared by the FDA and introduced to US customers at that time: the Cataract App (including integrated monofocal and toric IOL calculators), the Cornea App (including corneal geometry measurements), and a Metrics App (including swept-source OCT images, a radial view of the anterior chamber, and free-hand measurements).

Jeffrey Fischer, MD, served as principal investigator of the ANTERION Epithelial Thickness Module clinical trial. In the press release from Heidelberg Engineering, he stated, "The Epithelial Thickness Module…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."

References

1. FDA Clears Epithelial Thickness Module for Heidelberg Engineering’s ANTERION® Multidisciplinary Imaging Platform, Advancing Precision in Corneal Health Assessment. News release. Heidelberg Engineering. Published January 9, 2025. Accessed January 9, 2025.

2. Hayes H. ANTERION diagnostic platform cleared by the FDA. Ophthalmology Times Europe. Published October 13, 2023. Accessed January 9, 2025. https://www.ophthalmologytimes.com/view/anterion-diagnostic-platform-cleared-by-the-fda