FDA Radiology AI Devices

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 Notal Vision Home OCT System is an AI-based home use device that enables patients with neovascular age-related macular degeneration (NV-AMD) to self-image their eyes at home using Optical Coherence Tomography (OCT). It captures detailed images of the retina, segments and quantifies hypo-reflective spaces associated with fluid build-up, and securely transmits data for physician review between scheduled clinic visits. This allows more frequent monitoring of eye disease progression without replacing standard clinical examinations.