Intended Use

The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length covering cornea thickness, anterior chamber parameters, lens thickness, and axial length.

Technology

ANTERION employs swept-source optical coherence tomography (SS-OCT) and an infrared (IR) camera for en-face imaging. The device has hardware components (laser, detectors, optics) and software applications (Imaging App, Cornea App, Cataract App, Metrics App) with AI-assisted analysis for detailed imaging and quantification of the eye's anterior segment. It uses motorized positioning and offers interface with medical image management systems.

Performance

Clinical studies comparing ANTERION with the CIRRUS HD-OCT 5000 demonstrate the device provides repeatable, reproducible, and accurate measurements of corneal epithelial thickness and anterior segment parameters. The device showed generally better or comparable precision and higher acquisition acceptability rates. No adverse events were reported, confirming safety.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    4/4/2024

    8 months
  • 2

    FDA Approval

    12/13/2024

Other devices from Heidelberg Engineering GmbH

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