Heidelberg Engineering Announces FDA Clearance for All-in-One ANTERION Platform

Heidelberg Engineering, a global leader in ophthalmic imaging and healthcare data solutions, announces FDA clearance of its innovative all-in-one ANTERION® platform, designed to transform anterior segment diagnostics and streamline practice workflow.

“Building upon our previous CE-marking, we are thrilled that the ANTERION platform is now available to eye care providers across the U.S.,” said Arianna Schoess Vargas, Managing Director of Heidelberg Engineering GmbH. “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.”

As an all-in-one upgradeable platform, ANTERION combines biometry, IOL power calculation with corneal topography and tomography, anterior chamber metrics, and high-resolution imaging to help revolutionize the day-to-day clinical routine. Additional proprietary features such as patented eye tracking and composite imaging technologies help deliver exceptional Heidelberg image quality, allowing eye care professionals to perform anterior segment examinations and acquire key measurements via high-resolution swept-source OCT images that support clinical decision-making and increase diagnostic confidence.

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

Central to the ANTERION platform is the Imaging App, which was FDA cleared in November 2021. The Imaging App focuses on the high-resolution visualization of the anterior segment and delivers impressive and revealing OCT images that assist eye doctors in the diagnosis and management of anterior segment alterations. ANTERION’s functionality has been expanded with the newly FDA cleared apps designed to meet a variety of clinical needs:

  • The Cataract App combines key measurements for cataract surgery planning, including integrated monofocal and toric IOL calculators. The ability to assess corneal wavefront and total power supports a more suitable IOL selection and helps avoid refractive surprises even in challenging eyes.
  • The Cornea App provides a comprehensive set of corneal measurements for the evaluation of a patient’s individual corneal geometry. These diagnostic insights can be used to help support the surgical planning and evaluation of refractive procedures.
  • The Metrics App features swept-source OCT images with the anterior chamber displayed in a radial view. Predefined angle parameters can be determined, and free-hand measurements can also be performed.

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