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 Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device designed to photograph, display, and store images of the retina under non-mydriatic conditions. It aids clinicians in the evaluation, diagnosis, and documentation of ocular health by providing high quality retinal images.

The SPECTRALIS with Flex Module is an advanced eye imaging device designed for non-contact visualization of the posterior segment and vasculature of the retina and choroid in adults and pediatric patients, including those in supine (lying down) position. It helps ophthalmologists detect and monitor various eye conditions by providing high-quality images of eye structures, enabling improved diagnosis and 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.

The AEYE-DS device helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes by analyzing retinal images taken by specific fundus cameras. It uses AI technology to analyze the images and provides diagnostic screening results, improving early detection and management of diabetic eye disease.

EyeArt v2.2.0 is an AI-based software device designed to automatically detect more than mild and vision-threatening diabetic retinopathy in retinal fundus images. It assists healthcare providers by analyzing images captured from specific retinal cameras and providing diagnostic screening results to help identify retinal disease in adults with diabetes, facilitating early detection and treatment.

AEYE-DS is an AI-powered retinal diagnostic software that helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes using fundus images from a Topcon NW400 camera. It improves screening efficiency by analyzing images to identify disease presence, helping to guide timely patient care.

IDx-DR v2.3 is an AI-based diagnostic software that automatically detects more than mild diabetic retinopathy from retinal images captured with a Topcon NW400 fundus camera. It helps healthcare providers identify patients who need referral to eye care professionals, improving timely diagnosis and management of diabetic retinopathy.

IDx-DR is an AI software device designed to help healthcare providers automatically detect more than mild diabetic retinopathy in diabetic adult patients using retinal fundus images. It assists clinicians by analyzing images captured from a specialized retinal camera and providing a diagnostic screening result, thus potentially improving early detection and management of diabetic eye disease.

EyeArt is an AI-powered medical software that analyzes retinal images to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy in adults with diabetes. It is designed to assist healthcare providers in primary care and eye care settings by providing rapid and reliable detection using color fundus images captured by specified retinal cameras.