ANTERION diagnostic platform cleared by the FDA

(Image Credit: AdobeStock)

Heidelberg Engineering announced that it received clearance from the FDA for its ANTERION imaging and workflow platform. In Europe, the ANTERION already received a CE mark; the FDA clearance will expand availability to the United States.

According to a press release from Heidelberg Engineering, the ANTERION combines proprietary features with best-in-class diagnostic tools, such as IOL power calculation with corneal topography and tomography, high-resolution imaging and anterior chamber metrics. Additionally, the ANTERION features “patented eye tracking and composite imaging technologies” unique to Heidelberg.¹

In 2021, the FDA cleared Heidelberg Engineering’s Imaging App for anterior segment visualization. The ANTERION system will work with the Imaging App, and a suite of new apps recently cleared by the FDA. Those new additions include 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).

The ANTERION will work in conjunction with FDA-approved apps for imaging, metrics, cornea and cataract care. Image courtesy of Heidelberg Engineering GmbH.

Arianna Schoess Vargas, managing director of Heidelberg Engineering GmbH, said the company is “thrilled” to make the ANTERION available to providers in the US. “We believe this device complements our current portfolio of products and arms anterior segment focused practices with the comprehensive data needed to support diagnostic decisions that ultimately improve patient care,” she said in the news release.

Mitchell W. Dul, OD, MS, principal investigator of the ANTERION clinical trial, spoke about the capabilities of the imaging device. "We were impressed by the high-quality images and measurements of the anterior segment that ANTERION offers,” he said. “Its multi-faceted utility, high resolution, rapid image acquisition, and intuitive user interface will make this device an invaluable tool for clinical practice."

Reference

1. Heidelberg Engineering Announces FDA Clearance for All-in-One ANTERION Platform. News release. Heidelberg Engineering GmbH. Published October 13, 2023.