Anterion is a non-contact ophthalmic imaging device that uses swept-source optical coherence tomography (SS-OCT) to visualize and measure the anterior segment of the eye, including corneal thickness, anterior chamber parameters, lens thickness, and axial length. It helps clinicians by providing detailed tomographic images and quantitative metrics critical for diagnosis and surgical planning, such as cataract surgery. The device includes multiple software applications for imaging and analysis and uses AI-powered processing for precise measurements, improving clinical decision-making and patient management.
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.
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.
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.
No predicate devices specified
Submission
4/4/2024
FDA Approval
12/13/2024
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